FDA approves Besremi, first treatment for a rare blood disease

The US Food and Drug Administration on Friday approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells.

Developed by Taiwan-based PharmaEssentia (TPEx: 6446), Besremi is the first FDA-approved medication for polycythemia vera that patients can take regardless of their treatment history, and the first interferon therapy specifically approved for polycythemia vera, the agency noted.

PharmaEssentia’s original Biologics License Application (BLA) received a complete response letter in March this year, in which the FDA sought additional information about the administration format with the product. The company resubmitted the BLA in May. The product was approved by the European Medicines Agency in 2019 and has received approval in Taiwan and South Korea.