On August 24, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company’s oral, next generation PI3K Delta inhibitor, TGR-1202, for the treatment of patients with chronic lymphocytic leukemia (CLL) (Press release, TG Therapeutics, AUG 24, 2016, View Source [SID:1234514703]). TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated CLL. Schedule your 30 min Free 1stOncology Demo! "We are pleased to receive orphan drug designation for TGR-1202. In addition to our composition of matter patent for TGR-1202 which issued earlier this year, the granting of this orphan drug designation offers an additional level of proprietary protection and also may provide us certain other regulatory and financial benefits," said Michael S. Weiss, Executive Chairman and Interim CEO of TG Therapeutics. "We continue to be excited about the differentiated safety profile of TGR-1202 over other PI3k delta inhibitors and believe the UNITY-CLL Phase 3 Trial will showcase those differences."
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Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.
Chronic lymphocytic leukemia (CLL) is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). CLL usually gets worse slowly and is one of the most common types of leukemia in adults. It often occurs during or after middle age. It is estimated that there are approximately 20,000 new cases of CLL diagnosed each year in the United States.
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Cell Medica and UCL collaborate to develop modified T cell receptor products for the treatment of cancer
On August 24, 2016 Cell Medica, a leader in developing, marketing and manufacturing cellular therapeutics for cancer and infections, reported that it has signed a research collaboration with UCL (University College London) aiming to utilize UCL’s novel T cell receptor (TCR) technology to generate leading-edge modified TCR products for the treatment of cancer (Press release, UCLB, AUG 24, 2016, View Source [SID:1234514681]). Schedule your 30 min Free 1stOncology Demo! The collaboration also provides Cell Medica with an exclusive worldwide option and license agreement for these technologies as well as TCR gene sequences for the development and commercialisation of specific products. The collaboration will build on the research of Professor Hans Stauss and Professor Emma Morris of UCL, global leaders in developing modified TCRs for cancer treatments.
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T cell receptors are molecules found on the surface of T cells which recognise antigens expressed by cancer cells. TCR technology exploits the ability of TCRs to target both intracellular and cell surface antigens, providing an important mechanism to engineer immune cells to target tumors. The UCL TCR technology has the potential to produce strong expression of TCRs by the engineered T cells which is expected to improve their efficacy in fighting tumors.
Collaboration structure
The collaboration will accelerate the pioneering work performed at the UCL Institute of Immunity and Transplantation (IIT) with grant support from Bloodwise, Medical Research Council and National Institute for Health Research (NIHR). The work is led by Professor Hans Stauss, Director of the IIT, and Professor Emma Morris, Director of the Infection, Immunity and Inflammation research theme at the NIHR University College London Hospitals Biomedical Research Centre, both based at the Royal Free Hospital, a UCL Partners academic health science center.
UCL will conduct the preclinical and early clinical research under the guidance of a Joint Steering Committee. Cell Medica will support the product development work with its substantial experience in manufacturing clinical-grade cell therapies and establishing robust production processes suitable for industrial scale-up. Following completion of successful first-in-man studies, the products will transfer to Cell Medica for later-stage clinical development and commercialization.
License, option and sponsored research agreement
Cell Medica has entered into an exclusive license and option agreement with UCL Business, the technology commercialisation company of UCL, for the dominant TCR platform patent and two target antigens. As part of this agreement, both parties can bring targets or platform technologies to the collaboration, aiming to generate leading-edge modified TCR products. In addition, UCL and Cell Medica have signed a Sponsored Research Agreement under which Cell Medica will fund all research and development with an exclusive option to license all products developed within the collaboration.
Cell Medica has paid an up-front fee and will make additional payments to exercise its exclusive option to license future products. UCL is eligible to receive further payments related to clinical, regulatory and sales milestones, as well as single digit royalties.
Gregg Sando, CEO of Cell Medica said:
"This collaboration adds the modified TCR technology platform to our strategy to develop breakthrough treatments for cancer using cellular immunotherapy products. The partnership with Profs Hans Stauss and Emma Morris, leading researchers in this field, should enable us to generate a pipeline of new TCR products with increased efficacy and safety for patients."
Professor Hans Stauss, Director of the Institute of Immunity and Transplantation at the Royal Free Hospital, a UCL Partners academic health science centre, said:
"This collaboration provides an exciting opportunity to move our TCR gene therapy technologies more effectively towards clinical application. We are grateful to the blood cancer charity Bloodwise, who have provided important long-term support for our work. The new collaboration with Cell Medica enables us to take full advantage of our pre-clinical research and rapidly develop novel TCRs for the treatment of patients with cancer"
Professor Emma Morris, Director of the Infection, Immunity and Inflammation research theme at the National Institute for Health Research University College London Hospitals Biomedical Research Centre, and Professor of Clinical Cell and Gene Therapy said:
"As a clinician treating patients with blood cancers, I am aware of the urgent need to develop more effective and less toxic therapies. Immunotherapy with gene-modified immune cells has enormous potential to transform the lives of cancer patients. It is truly exciting to be supported by Cell Medica to accelerate our progress in developing new therapies."
Dr Alasdair Rankin, Research Director at Bloodwise, said:
"Having supported the UCL team’s work for many years, it is exciting to see their hugely promising research reach this stage. This important collaboration is a vital step in the development of new treatments that could have a significant impact on outlook for many patients."
IMMUNE THERAPEUTICS, INC., THROUGH ITS WHOLLY OWNED
SUBSIDIARY TNI BIOTECH INTERNATIONAL, LTD.,
INITIATES CLINICAL TRIAL IN MALAWI WITH LDN FOR THE
PREVENTION OF CERVICAL CANCER
On August 23, 2016 Immune Therapeutics, Inc. (OTCQB-IMUN) ("IMUN"), a clinical-stage biopharmaceutical company involved in the commercialization, manufacturing, distribution and marketing of its novel immunotherapies to combat chronic, life-threatening diseases through the activation and modulation of the body’s immune system reported that through its wholly owned subsidiary TNI Biotech International, Ltd. it has initiated a clinical trial in Malawi LDN for the prevention of cervical cancer (Filing, 8-K, TNI BioTech, AUG 23, 2016, View Source [SID:1234514706]).
IMUN, in conjunction with the College of Medicine Malawi, has initiated a clinical study with LDN for the prevention of cervical cancer. This is an open-label, multicenter study designed to determine the safety and acceptability of a single-visit approach to cervical cancer prevention in patients. Using a single-visit approach to prevent cervical cancer, women will be examined through visual inspection of the cervix with acetic acid wash (VIA) and, if tests results are positive, patients will be offered immediate cryotherapy of the precancerous lesion. The secondary objectives are to determine life extension, to improve the immune system of immune comprised patients by starting treatment with LDN.
The Brewer Foundation in partnership with IMUN arranged both the funding for the trial and the donation of the Wallach LL100 Cryosurgical system necessary to run the trial and treat patients.
"The joint goal of this ever-important initiative is to empower the people of Malawi and to provide affordable health solutions to those most vulnerable. With this trial, we, with IMUN and its subsidiaries, hope to combat cervical cancer and immediately start saving lives in our ongoing initiative to improve global health," stated His Excellency, Ambassador Jack Brewer, Founder and Executive Director of JBF Worldwide.
Noreen Griffin, Chief Executive Officer of IMUN, said "With the increase in the number of patients in Africa suffering from cancer, the need for affordable non-toxic therapies becomes more important every day. We, with our partners GB Pharma and The Jack Brewer Foundation, intend to be part of finding a solution."
Dr. Frank Taulo, the head of the OBGYN Department for Queen Elizabeth Central Hospital in Blantyre and Principal Investigator of the trial, explained, "Since the beginning of the cervical cancer prevention programme in Malawi, strides have been made regarding scaling up of the screening services and premalignant lesions treatment using cryotherapy. One of the biggest challenges has been the inadequate cryotherapy medical device. The timely donation of 10 cryotherapy guns has alleviated tremendously this anomaly. Now several centers are able to treat these lesions."
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Medtronic Completes Acquisition of HeartWare International
On August 23, 2016 Medtronic plc (NYSE: MDT), the global leader in medical technology, reported that it has completed its acquisition of HeartWare International, Inc., a leading innovator of less-invasive, miniaturized, mechanical circulatory support technologies (MCS) for treating patients with advanced heart failure (Press release, Medtronic, AUG 23, 2016, View Source;p=RssLanding&cat=news&id=2196837 [SID:1234514704]). HeartWare will become part of the Heart Failure business within the Medtronic Cardiac Rhythm and Heart Failure division. Under the terms of the transaction, each outstanding share of HeartWare common stock has been converted into the right to receive $58.00 in cash, without interest, subject to any required withholding of taxes.
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HeartWare develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices (VAD), to treat patients around the world suffering from advanced heart failure. Its flagship product, the HVAD System, features the world’s smallest full-support VAD and is indicated for refractory end-stage left-ventricular heart failure patients in the U.S. who are awaiting a heart transplant, as well as approved in Europe for long-term use in patients at risk of death from refractory, end-stage heart failure.
Medtronic estimates that the global VAD market is approximately $800 million currently, and worldwide is expected to grow in the mid-to-high single digits for calendar years 2016-17, and accelerate to high-single/low-double digits beyond calendar year 2017.
"Not only does the current HeartWare portfolio expand Medtronic leadership across the heart failure continuum, its product pipeline – when married with our expertise – can result in progressively less-invasive heart pumps that have the potential to benefit even more patients," said David Steinhaus, M.D., vice president and general manager of the Heart Failure business, and medical director for the Cardiac Rhythm and Heart Failure division at Medtronic. "Today, Medtronic offers the industry’s leading cardiac resynchronization therapy devices, including MR-conditional CRT-defibrillators; MCS therapy for advanced heart failure patients; heart failure diagnostics; and meaningful expert analysis through Medtronic Care Management Services, including the recently launched Beacon Heart Failure Management Service."
The acquisition of HeartWare broadens the Medtronic portfolio of therapies, diagnostic tools and services for patients suffering from heart failure, aligning with Medtronic’s Mission of alleviating pain, restoring health and extending life. The acquisition is part of the Company’s therapy innovation strategy to surround the physician with innovative products while focusing on patients and disease states.
"This is an exciting moment, as more than 600 HeartWare employees are now part of the broader Medtronic organization," said Doug Godshall, who served as president and chief executive of HeartWare for the past decade. "HeartWare has delivered incredible advancements for patients suffering from heart failure, through the commercialization of the HVAD system and pipeline development, and I am convinced that being part of Medtronic will allow us to accelerate meaningful innovations even more quickly."
Heart failure, also known as congestive heart failure, is a condition in which the heart isn’t pumping enough blood to meet the body’s needs. Heart failure usually develops slowly after an injury to the heart. Some injuries may include a progressive deterioration of the heart muscle, heart attack, untreated high blood pressure, or heart valve disease. Heart failure remains a leading cause of hospitalization and death in the United States, and its prevalence continues to increase, affecting more than 5 million people in the U.S. alone. The cost of heart failure is high. Healthcare expenditures in the U.S. on heart failure are estimated to be approximately $39 billion per year, making it one of the largest expenses to the healthcare system. With the aging of the population, Medtronic estimates that the number of patients with heart failure could exceed 8 million by 2030.
This transaction is expected to meet Medtronic’s long-term financial metrics for acquisitions. Medtronic does not intend to modify its fiscal year 2017 revenue outlook or earnings per share (EPS) guidance as a result of this transaction, although it is expected to provide increased confidence in the company’s ability to deliver on its FY17 revenue growth outlook. In addition, Medtronic expects minimal to no net EPS dilution from this transaction for the first two years as the company intends to offset the expected dilutive impact. The acquisition is expected to be earnings accretive in year three.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
The Tender Offer and Merger
The tender offer for all of the outstanding shares of HeartWare common stock expired as scheduled immediately after 11:59 p.m. Eastern time on August 22, 2016. Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Medtronic that 14,952,817 shares of HeartWare common stock were validly tendered and not properly withdrawn in the tender offer, representing approximately 85.15% of the outstanding shares. All of the conditions to the tender offer have been satisfied, and on August 23, 2016, Medtronic Acquisition Corp., a subsidiary of Medtronic, accepted for payment and will promptly pay for all shares validly tendered and not properly withdrawn in the tender offer.
Following acceptance of the tendered shares, Medtronic completed its acquisition of HeartWare through the merger of Medtronic Acquisition Corp. with and into HeartWare without a vote of HeartWare’s stockholders pursuant to Section 251(h) of the Delaware General Corporation Law. As a result of the merger, HeartWare became a wholly-owned subsidiary of Medtronic. In connection with the merger, all HeartWare shares not validly tendered into the tender offer (other than shares (i) owned by HeartWare as treasury stock or owned by Medtronic, Inc. or Medtronic Acquisition Corp., which shares were cancelled and retired and cease to exist or (ii) held by any person who was entitled to and has properly demanded statutory appraisal of his or her shares) have been cancelled and converted into the right to receive the same $58.00 per share in cash, without interest, subject to any required withholding of taxes, as will be paid for all shares that were validly tendered and not properly withdrawn in the tender offer. HeartWare common stock will cease to be traded on The NASDAQ Stock Market LLC.
Bristol-Myers Squibb and Pfizer to Present New Eliquis (apixaban) Analyses at ESC Congress 2016
On August 23, 2016 Bristol-Myers Squibb Company (link is external) (NYSE: BMY) and Pfizer Inc.(NYSE: PFE) reported that 19 abstracts (late-breaking, rapid-fire, oral and poster presentations) will be presented at ESC Congress 2016, to be held August 27–31 in Rome, Italy (Press release, Pfizer, AUG 23, 2016, View Source [SID:1234514680]). These new data from post-hoc analyses from ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) and retrospective real-world data analyses continue to underscore the Alliance’s commitment to the evaluation of Eliquisfor patients with nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). Of note, several of the real-world data analyses are part of ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies), a global real-world data research program designed to further evaluate the effectiveness and safety of apixaban in routine clinical practice.
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"The Bristol-Myers Squibb and Pfizer Alliance is pleased to share 19 abstracts, which include new real-world analyses, as well as new sub-analyses from the pivotal Phase 3 ARISTOTLE trial," said Rory O’Connor, M.D., Chief Medical Officer, Internal Medicine, Pfizer Innovative Health. "We look forward to the opportunity to contribute to the scientific discussion and continued research during ESC Congress 2016."
"As patient and provider needs continue to evolve, it’s essential that we deepen our understanding of how medicines are working in real-world situations," said Jack Lawrence, M.D., Vice President, Cardiovascular Specialty Development, Bristol-Myers Squibb. "This year at ESC Congress 2016, we’ll be discussing new NVAF and VTE data that complement our robust body of clinical trial data."
The complete list of Bristol-Myers Squibb and Pfizer Alliance presentations is included below. Abstracts can be accessed on the ESC Congress 2016 website (link is external).
Title Presenting Author/Type Date/Time (BST) Location/Session
Phase 3 Clinical Trial Sub-Analyses
Patients with Atrial Fibrillation and History of Falls Are at High Risk for Bleeding but Have Less Bleeding with Apixaban than Warfarin: Results from the ARISTOTLE Trial
Session: New Trends in Antithrombotic Therapy for Atrial Fibrillation
Rao et al. /
Oral, Rapid Fire
Aug. 28,
11:10
Agora 1 – Poster Area
Efficacy and Safety of Apixaban versus Warfarin in Patients with Atrial Fibrillation and Active Cancer: Insights from the ARISTOTLE Trial
Session: New Trends in Antithrombotic Therapy for Atrial Fibrillation
Melloni et al. /
Oral, Rapid Fire
Aug. 28,
11:20
Agora 1 – Poster Area
Patients with Atrial Fibrillation Treated with Apixaban Are Less Likely to Discontinue Study Drug When Compared with Warfarin: Insights from the ARISTOTLE Trial
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation III
Xavier et al. /
Poster
Aug. 28,
14:00
Poster Area
Real-World Data and Other Analyses
Contemporary Results from EHR Study of Real-World Bleeding Risk among Elderly and Overall Non-Valvular Atrial Fibrillation Patients Prescribed Apixaban, Dabigatran, Rivaroxaban and Warfarin
Session: New Trends in Antithrombotic Therapy for Atrial Fibrillation
Horblyuk et al. /
Oral, Rapid Fire
Aug. 28,
12:00
Agora 1 – Poster Area
Real-World Comparisons of Major Bleeding Risk and Major Bleeding-Related Hospitalization Costs among Elderly Non-Valvular Atrial Fibrillation Patients Newly Initiated on Apixaban or Warfarin
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation
Lip et al. /
Poster
Aug. 28,
14:00
Poster Area
Is Major Bleeding Risk for Oral Anticoagulants Similar Between Non-Valvular Atrial Fibrillation Patients Newly Initiated on Warfarin and Propensity-Score Matched NOAC Initiators? A Real World Study
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation
Lip et al. /
Poster
Aug. 28,
14:00
Poster Area
Major Bleeding Risk in Patients 75 Years of Age or Older with Non-Valvular Atrial Fibrillation Initiating Oral Anticoagulants: A ‘Real-World’ Comparison of Warfarin, Apixaban, Dabigatran, or Rivaroxaban
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II
Lip et al. /
Poster
Aug. 28,
14:00
Poster Area
Is There a Difference in Treatment Persistence Across Oral Anticoagulants? Results of a UK Cohort Study Evaluating Oral Anticoagulation Therapy in an Atrial Fibrillation Population
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation
Stynes et al. /
Poster
Aug. 28,
14:00
Poster Area
Real-World Comparison of Major Bleeding and Associated Costs among Treatment-Naïve Non-Valvular Atrial Fibrillation Patients Initiating Apixaban or Warfarin
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II
Trocio et al. /
Poster
Aug. 28,
14:00
Poster Area
Aspirin, not without Bleeding Risk in the Real World: Results of a UK Cohort Study Evaluating the Use of Antiplatelet Therapy for Stroke Prevention in Atrial Fibrillation (AF)
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation III
Ridha et al. / Poster
Aug. 28,
14:00
Poster Area
Is Aspirin Monotherapy Effective for Stroke Prevention in the Real World? A UK Cohort Study Evaluating the Incidence of Stroke in the Absence of Anticoagulation in Atrial Fibrillation (AF)
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II
Ridha et al. /
Poster
Aug. 28,
14:00
Poster Area
Differences in the Characteristics of Patients with Non-Valvular Atrial Fibrillation Who Are Newly Prescribed Apixaban, Rivaroxaban, Dabigatran and VKA in General Practice in the UK
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation
Stynes et al. /
Poster
Aug. 28,
14:00
Poster Area
Risk of Bleeding with Non-Vitamin K Antagonists and Phenprocoumon in Routine Care Patients with Non-Valvular Atrial Fibrillation
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation III
Hohnloser et al. /
Poster
Aug. 28,
14:00
Poster Area
Are Your Atrial Fibrillation (AF) Patients Protected from Ischaemic Stroke? Clinical Characteristics of AF Patients Eligible for Stroke Prevention but Remaining Untreated in UK Clinical Practice
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II
Ridha et al. /
Poster
Aug. 28,
14:00
Poster Area
Bleeding Risk for Non-Valvular AF Patients Prescribed Warfarin, or Standard Doses of Apixaban 5mg BID, Dabigatran 150mg BID or Rivaroxaban 20mg QD in Real-World Practice: Findings from EHR
Session: Are You Still Afraid about Bleeding Risk of Antithrombotic Therapy in Atrial Fibrillation?
Lip et al. /
Oral, Advances in Science
Aug. 28,
14:18
Minsk – Village 4
Demographic and Clinical Characteristics Associated with Initiation of Individual Oral Anticoagulants among Patients with Newly Diagnosed Venous Thromboembolism
Session: Poster Session 4: Thrombosis and Coagulation
Li et al. /
Poster
Aug. 29,
08:30
Poster Area
A Nationwide Register Study to Compare Bleeding Rates in Patients with Non-Valvular Atrial Fibrillation Prescribed Oral Anticoagulants
Session: Registries Atrial Fibrillation
Halvorsen et al. /
Late-Breaker
Aug. 29,
08:45
Raphael – The Hub
Costs of Major Adverse Outcomes in Patients with Incident Venous Thromboembolism in Clinical Practice in the United Kingdom
Session: Advances in Pulmonary Embolism
Cohen et al. /
Poster
Aug. 29,
16:03
Moderated Poster Station – Poster Area
Potential Impact of Apixaban on Hospital Resource Use in Patients with Venous Thromboembolism
Session: Antithrombotics in Daily Clinical Practice
Li et al. /
Oral, Rapid Fire
Aug 30,
17:24
Galileo – The Hub
About Eliquis
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquisdecreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the U.S. based on efficacy and safety data from seven Phase 3 clinical trials. Eliquis is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF); for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE, following initial therapy.
ELIQUIS Indications and Important Safety Information
Indications
ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
ELIQUIS is indicated for the treatment of DVT and PE, and to reduce the risk of recurrent DVT and PE following initial therapy.
ELIQUIS Important Safety Information
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
(A) Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
(B) Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
use of indwelling epidural catheters
concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
a history of traumatic or repeated epidural or spinal punctures
a history of spinal deformity or spinal surgery
optimal timing between the administration of ELIQUIS and neuraxial procedures is not known
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.
CONTRAINDICATIONS
Active pathological bleeding
Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS
Increased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including ELIQUIS, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in atrial fibrillation patients. If ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
Bleeding Risk: ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding.
Concomitant use of drugs affecting hemostasis increases the risk of bleeding, including aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs.
Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage.
There is no established way to reverse the anticoagulant effect of apixaban, which can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). A specific antidote for ELIQUIS is not available.
Spinal/Epidural Anesthesia or Puncture: Patients treated with ELIQUIS undergoing spinal/epidural anesthesia or puncture may develop an epidural or spinal hematoma which can result in long-term or permanent paralysis.
The risk of these events may be increased by the postoperative use of indwelling epidural catheters or the concomitant use of medicinal products affecting hemostasis. Indwelling epidural or intrathecal catheters should not be removed earlier than 24 hours after the last administration of ELIQUIS. The next dose of ELIQUIS should not be administered earlier than 5 hours after the removal of the catheter. The risk may also be increased by traumatic or repeated epidural or spinal puncture. If traumatic puncture occurs, delay the administration of ELIQUIS for 48 hours.
Monitor patients frequently and if neurological compromise is noted, urgent diagnosis and treatment is necessary. Physicians should consider the potential benefit versus the risk of neuraxial intervention in ELIQUIS patients.
Prosthetic Heart Valves: The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients.
Acute PE in Hemodynamically Unstable Patients or Patients who Require Thrombolysis or Pulmonary Embolectomy: Initiation of ELIQUIS is not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
ADVERSE REACTIONS
The most common and most serious adverse reactions reported with ELIQUIS were related to bleeding.
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS
ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be noncritical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.
DRUG INTERACTIONS
Strong Dual Inhibitors of CYP3A4 and P-gp: Inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) increase exposure to apixaban and increase the risk of bleeding. For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose of ELIQUIS by 50% when ELIQUIS is coadministered with drugs that are strong dual inhibitors of CYP3A4 and P-gp (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin). In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp.
Strong Dual Inducers of CYP3A4 and P-gp: Avoid concomitant use of ELIQUIS with strong dual inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) because such drugs will decrease exposure to apixaban and increase the risk of stroke and other thromboembolic events.
Anticoagulants and Antiplatelet Agents: Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of bleeding with apixaban compared to placebo.
PREGNANCY CATEGORY B
There are no adequate and well-controlled studies of ELIQUIS in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. ELIQUIS should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.
Please see full Prescribing Information, including BOXED WARNINGS and Medication Guide, available atwww.bms.com (link is external).
About ACROPOLIS
ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) is the Eliquis (apixaban) global real-world data program designed to generate additional evidence from routine clinical practice settings to further inform healthcare decision makers, including healthcare providers and payers. The ACROPOLIS program will include retrospective, outcomes-based analyses from over 10 databases around the world, including medical records, medical and pharmacy health insurance claims data, and national health data systems.
Analyses of real-world data allow for a broader understanding of patient outcomes associated with Eliquis outside of the clinical trial setting, as well as insight into other measures of healthcare delivery, such as hospitalization and costs.
About ARISTOTLE
ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) was designed to evaluate the efficacy and safety of Eliquis versus warfarin for the prevention of stroke or systemic embolism. In ARISTOTLE, 18,201 patients were randomized (9,120 patients to Eliquis and 9,081 to warfarin). ARISTOTLE was an active-controlled, randomized, double-blind, multi-national trial in patients with nonvalvular atrial fibrillation or atrial flutter, and at least one additional risk factor for stroke. Patients were randomized to treatment with Eliquis 5 mg orally twice daily (or 2.5 mg twice daily in selected patients, representing 4.7 percent of all patients) or warfarin (target INR range 2.0-3.0), and followed for a median of 1.8 years.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb’s long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.