On December 17, 2018 AOP Orphan Pharmaceuticals AG (AOP Orphan) reported that EMA´s CHMP adopted a positive opinion for approval of Ropeginterferon alfa-2b/BESREMi indicated as monotherapy in adults for the treatment of Polycythaemia vera without symptomatic splenomegaly (Press release, AOP Orphan Pharmaceuticals, DEC 17, 2018, View Source [SID1234533574]).
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Ropeginterferon alfa-2b/BESREMi is a novel, long-acting interferon, which is administered once every two weeks, or monthly after stabilization of hematological parameters. This treatment schedule is expected to lead to overall better safety, tolerability and adherence compared to conventional pegylated interferons.
AOP Orphan has been running the BESREMi clinical development in PV since 2010. The latest phase III data, three years treatment, and phase II data, up to seven years treatment, were presented at ASH (Free ASH Whitepaper) 2018. In summary, BESREMi showed high hematologic and clinical response rates with good tolerability.
In addition, BESREMi showed high molecular response rates, associated with the ability to reduce allelic burden of both mutant JAK2 and importantly also non-JAK2 mutations, which are believed to have a role in disease progression.
Andreas Steiner, Chief Executive Officer of AOP Orphan commented: "Although interferons are a treatment modality widely used throughout the myeloproliferative neoplasms including CML, BESREMi will be the first licensed interferon in any of these indications. Physicians experienced in the management of the disease and administration of BESREMi during the clinical studies expect many advantages for the patients with PV."
About Ropeginterferon alfa-2b/BESREMi
Ropeginterferon alfa-2b/BESREMi is a novel, long-acting, mono-pegylated proline interferon (ATC L03AB15) with improved pharmacokinetic properties offering improved tolerability and adherence to treatment. It is administered once every two weeks, or monthly during long-term maintenance, and is expected to be the first interferon approved for PV worldwide.
Ropeginterferon alfa-2b was discovered by PharmaEssentia, a long-term partner of AOP Orphan. In 2009, AOP Orphan has in-licensed from PharmaEssentia Corporation the exclusive rights for clinical development and commercialization of Ropeginterferon alfa-2b in PV, other MPNs and CML for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.
About Polycythemia Vera
Polycythemia Vera (PV) is a cancer of the blood-building cells in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. This condition may result in circulatory disorders such as thrombosis and embolism, as well as malignant transformation to myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2 that make the malignant clone.