Besremi FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 14, 2021.

FDA Approved: Yes (First approved November 12, 2021)
Brand name: Besremi
Generic name: ropeginterferon alfa-2b-njft
Dosage form: Injection
Company: PharmaEssentia Corporation
Treatment for: Polycythemia Vera

Besremi (ropeginterferon-alfa-2b-njft) is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera.

• Polycythemia vera is a rare, chronic and life-threatening disorder caused by a defective hematopoietic stem cell in the bone marrow, which results in a chronic increase of red blood cells, white blood cells, and platelets. This can cause cardiovascular complications such as thrombosis and embolism, and can progress to secondary myelofibrosis or leukemia. Most cases are caused by a JAK2V617F mutation in the JAK2 gene.
• Besremi is a type I interferon that works to treat polycythemia vera by binding to the interferon alfa receptor (IFNAR) in the bone marrow. It has an inhibitory effect on the proliferation of hematopoietic stem cells, and is thought to decrease the mutated JAK2V617F allele burden.
• Besremi is a monopegylated, long-acting interferon with a long duration of activity. It is administered by subcutaneous injection every 2 weeks or longer until hematologic parameters are stabilized. After one year, patients with stable complete hematologic response (CHR) can be treated every four weeks.
• The Besremi product label carries a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.
• Common adverse reactions include influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, and musculoskeletal pain.

Development timeline for Besremi

Further information

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