Mimrylo Snags FDA Approval for First-of-Its-Kind Polycythemia Vera Treatment
In a 293-patient trial, 76.9% of treated patients needed no phlebotomy over 32 weeks, compared with 32.9% on placebo.
- On Friday, the Food and Drug Administration approved Mimrylo, a new weekly injectable treatment for polycythemia vera, a rare blood cancer causing excessive red blood cell production.
- Polycythemia vera affects an estimated 90,000 people in the United States, with the primary treatment goal being keeping hematocrit below 45 percent, often requiring frequent therapeutic phlebotomy that can drive iron deficiency and fatigue.
- In the 293-patient VERIFY trial, 76.9 percent of patients taking Mimrylo required no phlebotomy over a 32-week period, compared to 32.9 percent of those receiving placebo.
- Takeda will sell Mimrylo for about $4,200 per vial, or around $218,000 annually, holding exclusive global rights after paying Protagonist Therapeutics $300 million upfront for development.
- Common side effects include injection site reactions and anemia, though Tanya Wroblewski, director of the FDA's Division of Nonmalignant Hematology, said the drug "offers a new, first-in-class option that has the potential to meaningfully reduce patient burden.
12 Articles
12 Articles
First-in-Class Takeda, Protagonist Drug Lands FDA Approval in Rare Blood Disorder
Takeda Pharmaceutical’s Mimrylo is now approved for treating polycythemia vera, a rare blood cancer with limited therapeutic options. Originally developed by Protagonist Therapeutics, the engineered peptide gives Takeda a drug with blockbuster sales potential as the pharma company’s top overall product faces patent expirations.
Protagonist Wins FDA Approval for MIMRYLO in Rare Blood Cancer Treatment
Protagonist Therapeutics (NASDAQ:PTGX) said the U.S. Food and Drug Administration has approved rusfertide, to be marketed as MIMRYLO, for the treatment of erythrocytosis in adults with polycythemia vera, or PV. The approval marks the company’s second FDA-approved medicine this year, following the M
Mimrylo snags FDA approval for first-of-its-kind polycythemia vera treatment
The FDA has approved a first-in-class therapy for the treatment of erythrocytosis for adults with polycythemia vera. Rusfertide (Mimrylo; Protagonist Therapeutics, Takeda) received approval for adults who have been unable to achieve adequate control with other therapies.
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