Takeda and Protagonist Therapeutics receive FDA approval for rusfertide (Mimrylo) to treat polycythemia vera
The FDA approved rusfertide, to be sold as Mimrylo, for the treatment of polycythemia vera, a rare blood cancer, marking a key win for Takeda and its partner Protagonist Therapeutics.
The decision relied on data from the Phase 3 VERIFY study, which showed that adding Mimrylo to standard care helped keep hematocrit levels below the 45% threshold that reduces clot risk.
Jefferies analysts estimate the drug could generate up to $2 billion in peak sales, adding to Takeda’s growth pipeline after a recent approval of its narcolepsy medicine Orzeyful.
The two approvals are described as the first major launches in Takeda’s next growth cycle, signaling momentum for the company’s upcoming product launches.
This writeup was produced by pharmadog from original reporting by BioSpace.
Original headline: “Takeda, Protagonist score broad FDA nod in rare blood cancer, setting up $2B opportunity”
read at BioSpace ↗
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