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Getting the latest healthcare news for you
Getting the latest healthcare news for you
The FDA has approved ropeginterferon alfa-2b (BESREMi) for adults with essential thrombocythemia (ET), marking the first new treatment for this rare blood disorder in nearly three decades. The long-acting interferon therapy works regardless of disease genotype and is available even for newly diagnosed patients. In the pivotal SURPASS ET trial, it dramatically outperformed anagrelide — 37.4% vs. 3.6% response rate.
The FDA has approved ropeginterferon alfa-2b (BESREMi, PharmaEssentia) for adults with essential thrombocythemia (ET), a rare blood disorder in which the bone marrow overproduces platelets, raising the risk of dangerous blood clots and bleeding. This marks the first new FDA-approved ET therapy in nearly 30 years — a significant milestone for patients who have had limited options for decades.
The approval covers use regardless of disease genotype or prior treatment status, including patients newly diagnosed and naive to cytoreductive therapy. Ropeginterferon already holds an existing indication for polycythemia vera, another rare blood disorder.
By the Numbers:
Why it matters: With no new ET approvals since the 1990s, BESREMi gives clinicians a powerful new tool — one that dramatically outperforms the current standard of care and offers flexibility across patient profiles, from newly diagnosed to treatment-resistant cases.
