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# PharmaEssentia Besremi sBLA for Essential Thrombocythemia.
- URL: https://www.fdaweb.com/pharmaessentia-besremi-sbla-for-essential-thrombocythemia/
- Published: 2026-01-13T12:00:00.000Z
- Updated: 2026-09-14T15:30:35.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160479

FDA has accepted for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi (ropeginterferon alfa-2b-njft) to include adults with essential thrombocythemia. The agency has set a user fee review action target date of 8/30.

If approved, the expanded indication would allow the drug’s use in adult patients with essential thrombocythemia, a rare myeloproliferative neoplasm characterized by excessive platelet production and an elevated risk of thrombosis, bleeding, and organ damage, according to the company. It notes that no new therapies have been approved in the U.S. for essential thrombocythemia in more than 20 years.

The submission is supported by results from the global Phase 3 SURPASS-ET study, as well as confirmatory evidence from the North American Phase 2b EXCEED-ET trial, the company says. Both studies demonstrated statistically significant and clinically meaningful outcomes in patients with essential thrombocythemia, it adds.

Besremi is currently approved in the U.S. for adults with polycythemia vera.