FDA approves Besremi for adults with essential thrombocythemia

The FDA has approved Besremi for adults with essential thrombocythemia, extending ropeginterferon alfa-2b-njft into a second myeloproliferative neoplasm indication in the United States.

Besremi is administered by subcutaneous injection and was evaluated in the randomised SURPASS ET study against anagrelide in adults with essential thrombocythemia.

The approval provides a new treatment option for a rare blood disorder characterised by excessive platelet production and associated risks of thrombosis and bleeding.

Field	Content
Alert Type	Approval
Regulatory Authority	U.S. Food and Drug Administration (FDA)
Product	Besremi (ropeginterferon alfa-2b-njft)
Company	PharmaEssentia
Indication	Treatment of adults with essential thrombocythemia
Therapy Area	Hematology / myeloproliferative neoplasms
Technology or Modality	Long-acting monopegylated interferon alfa
Geography	United States
What Happened	The FDA approved Besremi (ropeginterferon alfa-2b-njft) injection for the treatment of adults with essential thrombocythemia.
Dosing	The recommended starting dosage is 250 mcg by subcutaneous injection, increasing to 350 mcg at two weeks and a maintenance dosage of 500 mcg at four weeks, with maintenance dosing every two weeks unless modification is required for tolerability.
Supporting Evidence	The effectiveness of Besremi was evaluated in SURPASS ET, an open-label, multicentre, randomised study comparing Besremi with anagrelide in adults with essential thrombocythemia.
Why It Matters	Essential thrombocythemia can increase the risk of blood clots and bleeding because of excessive platelet production, and the approval provides another treatment option for affected adults.
Supporting Context	Besremi was already approved in the United States for polycythemia vera, another myeloproliferative neoplasm.
Potential Impact	The expanded indication could broaden use of ropeginterferon alfa-2b-njft across myeloproliferative neoplasms and provide physicians with an additional disease-directed treatment option.
Key Takeaway	FDA approval extends Besremi into essential thrombocythemia, giving adults with the rare blood disorder a newly authorised interferon-based treatment option.
What to Watch	Clinical adoption of Besremi in essential thrombocythemia and its positioning relative to established cytoreductive therapies.
Primary Source	U.S. Food and Drug Administration
Relevant Date	31 August 2026

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