BESREMi (Ropeginterferon) FDA Approved for Polycythemia Vera

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

View full Prescribing Information for BESREMi.

Detailed information can be found on the manufacturer’s website.

November 12, 2021, Burlington, MA – PharmaEssentia Corporation, 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.

PV is a rare, chronic and life-threatening blood cancer caused by a mutation in stem cells in the bone marrow, resulting in the overproduction of blood cells. When this occurs, it puts a person at risk for serious health problems, including blood clots, stroke and heart attack. Most cases are caused by a JAK2V617F mutation and, without proper management, this debilitating cancer can progress into myelofibrosis and malignancies, including acute myeloid leukemia.

“The FDA approval of BESREMi for people with polycythemia vera represents the next step in advancing patient care as it provides a critical addition to managing not only symptom burden and near-term complications, but also treating the cancer early, which may help reduce the risk of disease progression over time,” said Srdan Verstovsek, M.D., Ph.D., Director of the Hanns A. Pielenz Clinical Research Center for Myeloproliferative Neoplasms, Department of Leukemia at the University of Texas MD Anderson Cancer Center. “With the availability of an FDA-approved, next-generation interferon for this indication, it’s time that we focus on preserving the long-term health of patients with polycythemia vera.”