FDA Approves PharmaEssentia’s Besremi for Treating Rare Blood Disease

The FDA has approved PharmaEssentia’s Besremi (ropeginterferon alfa-2b), an injectable therapy for treating adults with polycythemia vera — a rare disease that causes red blood cell overproduction, boosting the chance of blood clots.

The approval was supported by a multicenter, single-arm trial lasting 7.5 years in which 51 adults suffering from the condition were given Besremi. The treatment’s success was measured by reduction in red blood cell volume, with 61 percent of patients having an effective response to the therapy.

The agency said Besremi is the first approved drug for polycythemia vera that patients may take “regardless of their treatment history.” A long-acting drug, Besremi should be taken by injection under the skin once every two weeks.