PharmaEssentia

The U.S. Food and Drug Administration has approved PharmaEssentia's BESREMi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythemia, a rare blood cancer, making it the first new FDA-approved treatment for this condition in nearly three decades. The approval, announced by PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation, applies to all adults with ET regardless of genotype or disease status, including newly diagnosed patients who have not received cytoreductive therapy. The decision is based on the global Phase 3 SURPASS ET study, which showed that BESREMi achieved superior durable response rates compared with anagrelide and reduced thromboembolic events over 12 months. BESREMi, a long-acting interferon-based therapy, is already approved for polycythemia vera, and this expansion follows recent regulatory approvals in Japan and Taiwan. The drug is expected to be available in the United States immediately.

PharmaEssentia USA Corporation announced FDA approval and the U.S. launch of the BESREMi Pen device for adult patients with polycythemia vera. The new pre-filled pen offers a more convenient self-administration option compared to the currently available pre-filled syringe and is expected to become commercially available in the coming weeks. Samuel Lin, Head of Global Operations at PharmaEssentia, called the approval a significant milestone that empowers patients to manage their condition with greater ease and confidence. Dr. John Mascarenhas of Mount Sinai noted the device has the potential to simplify self-administration and support better treatment adherence.