Burlington, Mass. — PharmaEssentia USA Corporation announced the U.S. Food and Drug Administration approval and launch of the BESREMi Pen, a pre-filled device containing ropeginterferon alfa-2b-njft for adults with polycythemia vera.
The company said the pen is designed to simplify self-administration and provide a more convenient alternative to the currently available pre-filled syringe. The device is expected to become commercially available in the United States in the coming weeks.
“The U.S. approval of the BESREMi Pen™ is a significant milestone both for our company, as well as the patients we serve,” said Samuel Lin, Head of Global Operations, PharmaEssentia. “With this new device, we’re empowering more people living with PV to manage their condition with greater ease and confidence. It reflects our continued commitment to delivering not only innovative therapeutics, but also smarter, more intuitive ways to support long-term care.”
“I’m very excited to see the FDA approval of the BESREMi Pen™ as a new option for patients,” said Dr. John Mascarenhas, Director of the Center of Excellence for Blood Cancers and Myeloid Disorders at Mount Sinai in New York City. “Treatment consistency is critical for managing PV, and this device has the potential to make a meaningful positive impact on patients’ lives by simplifying self-administration and supporting better adherence.”
Polycythemia vera is a blood cancer originating from a disease-initiating stem cell in the bone marrow. It causes a chronic increase in red blood cells, white blood cells and platelets and can lead to cardiovascular complications, including thrombosis and embolism. The disease may also progress to secondary myelofibrosis or leukemia.
BESREMi is approved by the FDA for the treatment of adults with polycythemia vera and holds U.S. orphan drug designation for the condition. PharmaEssentia has also submitted a supplemental biologics license application seeking to expand the drug’s label to include essential thrombocythemia.
The therapy has received regulatory approval in more than 40 countries, including approvals from the European Medicines Agency in 2019, the FDA in 2021 and Japan’s Pharmaceuticals and Medical Devices Agency in 2023.
PharmaEssentia USA, based in Burlington, Massachusetts, is a subsidiary of Taiwan-based PharmaEssentia Corporation. The biopharmaceutical company develops biologics for hematology, oncology and immunology indications and operates in the United States, Japan, China and Korea.
