Peptide News Digest

#Peptide-Therapeutic

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Regulatory · View digest

FDA Approves PharmaEssentia BESREMi (Ropeginterferon Alfa-2b-njft) for Adults With Essential Thrombocythemia; First New ET Therapy in Nearly 30 Years

PharmaEssentia announced Sunday August 30, 2026 FDA approval of BESREMi (ropeginterferon alfa-2b-njft, a monopegylated proline-modified recombinant interferon alfa-2b protein administered as biweekly subcutaneous injection) for adults with essential thrombocythemia (ET), a chronic BCR-ABL-negative myeloproliferative neoplasm characterized by excessive platelet production and increased thrombotic and hemorrhagic risk. Approval was received at the August 30 PDUFA target action date under the supplemental BLA that the FDA accepted January 2026. The approval covers adults with ET regardless of genotype or disease status (including newly-diagnosed patients naive to cytoreductive therapy) and expands the existing BESREMi commercial label (approved for polycythemia vera in November 2021). BESREMi is the first FDA-approved therapy for ET in nearly three decades — the standard-of-care landscape has been dominated by cytoreductive hydroxyurea, anagrelide, and off-label pegylated interferons plus low-dose aspirin. The ET approval follows the June 2026 Taiwan approval that marked BESREMi's first global regulatory clearance in ET.

Regulatory · View digest

FDA Approves Mimrylo (Rusfertide), the First-in-Class Hepcidin Mimetic Peptide, for Erythrocytosis in Polycythemia Vera

Takeda (NYSE: TAK) and Protagonist Therapeutics (NASDAQ: PTGX) announced Friday August 28, 2026 FDA approval of Mimrylo (rusfertide, a first-in-class subcutaneous synthetic hepcidin mimetic peptide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a rare BCR-ABL-negative myeloproliferative neoplasm in which uncontrolled red blood cell production drives increased thrombotic risk. Approval was based on the Phase 3 VERIFY trial (n=293) in which 76.9% of patients on rusfertide plus standard of care were phlebotomy-free through Week 32 versus 32.9% on placebo plus standard of care, with statistically significant improvements in hematocrit control and patient-reported fatigue and symptom burden. Adverse events were generally low-grade and included localized injection-site reactions (55.9%), anemia (15.9%), and fatigue (15.2%). Mimrylo will be commercialized by Takeda under the 2024 worldwide license and collaboration agreement with Protagonist and will ship within 48 hours. Jefferies analysts project peak sales potential of $2 billion. The mechanism (mimicking the natural iron-regulator hepcidin to constrain iron availability for erythropoiesis) is the first commercial validation of the hepcidin mimetic peptide class after more than a decade of academic development.