FDA Approves UDENYCA® Autoinjector

On March 6, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that the U.S. Food and Drug Administration ("FDA") approved a single-dose, prefilled autoinjector presentation of UDENYCA (pegfilgrastim-cbqv), a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia (Press release, Coherus Biosciences, MAR 6, 2023, View Source [SID1234628183]). The UDENYCA autoinjector has a streamlined, easy-to-use design for use in both in-office and at-home settings of care.

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"The introduction of the autoinjector option for UDENYCA, with the ability to be administered at home or in the doctor’s office, will provide increased choice and control for patients and physicians, ultimately making treatment more accessible to patients," said Dr. Lee Schwartzberg, Chief of Medical Oncology and Hematology at the Renown Health William N. Pennington Cancer Institute, and Professor of Clinical Medicine, University of Nevada. "There are certain types of cancer patients, those who live far away, have an active lifestyle, or who are supporting the needs of a busy family, for whom this option eliminates the need to return to the clinic and enables them to choose the time and place for treatment without having to wear an on-body device."

"The UDENYCA autoinjector represents the first innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative solutions that expand access and address the needs of patients undergoing cancer treatment," said Denny Lanfear, CEO of Coherus.

The UDENYCA autoinjector (AI) is an intuitive design with administration triggered by push-on-skin activation, immediately and reliably delivering a complete pegfilgrastim dose. The approval of UDENYCA AI was supported by a comprehensive analytical data package, as well as a pharmacokinetic, pharmacodynamic and immunogenicity study.1

Commercial availability of UDENYCA AI is planned for the second quarter of 2023.

About UDENYCA

UDENYCA is the only pegfilgrastim brand offering two on-demand options—prefilled syringe (PFS) and AI providing more choice and flexibility customized to meet the needs of patients and practices. UDENYCA (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) device is under review by the FDA. If approved, UDENYCA OBI would offer providers a highly desired alternative to the originator’s on-body pegfilgrastim delivery system. Since its launch in 2019, over 263,000 patients have been treated with UDENYCA.

INDICATION
UDENYCA is a leukocyte growth factor indicated to

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Limitations of Use: UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

WARNINGS AND PRECAUTIONS:

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS):
Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA in patients with serious allergic reactions.
Sickle cell crises: Severe and sometimes fatal crises have occurred. Discontinue UDENYCA if sickle cell crisis occurs.
Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA therapy is recommended.
Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.
Capillary Leak Syndrome: Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for sign and symptoms of MDS/AML in these settings.
Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA if aortitis is suspected.
Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.
ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Prescribing Information available at www.UDENYCA.com