U.S. FDA APPROVES BESREMi® (ROPEGINTERFERON ALFA-2B-NJFT) AS THE ONLY INTERFERON FOR ADULTS WITH POLYCYTHEMIA VERA
With deep, durable control demonstrated by over 7.5 years of clinical data, BESREMi® can be used at any point in the PV journey to support treatment goals
Milestone represents PharmaEssentia’s first approved indication in the United States
November 12, 2021, Burlington, MA – PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has approved BESREMi® (ropeginterferon alfa-2b-njft) for the treatment of adults with polycythemia vera (PV).
BESREMi is an innovative monopegylated, long-acting interferon, which exhibits its cellular effects in polycythemia vera in the bone marrow. BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic, and infections disorders. PharmaEssentia is preparing to make BESREMi available in the coming weeks in the U.S.