PharmaEssentia announced that Health Canada has granted a Notice of Compliance for BESREMi (ropeginterferon alfa-2b) for the treatment of adults with polycythemia vera (PV), a rare chronic blood cancer.
The therapy is a long-acting interferon designed for use in patients with PV, a myeloproliferative neoplasm characterized by overproduction of red blood cells. The condition is associated with increased blood viscosity and a heightened risk of complications including thrombosis, stroke, and progression to myelofibrosis or acute myeloid leukemia.
According to the company, BESREMi is expected to become available in Canada in the coming weeks. The drug has previously been approved in other markets for PV and is used as part of long-term disease management strategies.
Interferon therapies have been used in PV to control hematologic parameters and reduce symptom burden. Ropeginterferon alfa-2b is designed for less frequent dosing compared to earlier interferon formulations, with clinical data supporting hematologic and molecular responses in treated patients.
Clinicians note that treatment of PV focuses on reducing the risk of thrombotic events while managing disease-related symptoms over time. Available therapies include phlebotomy, cytoreductive agents, and interferons, depending on patient risk profiles.
The approval adds another treatment option for PV patients in Canada, where access to therapies tailored for long-term disease control has been evolving. Polycythemia vera typically requires lifelong management, with treatment approaches adjusted based on disease progression and patient-specific factors.
PharmaEssentia markets the therapy through its subsidiary, FORUS Therapeutics, in Canada.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!