Protagonist Therapeutics Says Rusfertide Gets US FDA Breakthrough Therapy Designation for Blood Condition Treatment
MT Newswires Live
Aug 25
Protagonist Therapeutics (PTGX) said Monday the US Food and Drug Administration has granted its drug candidate rusfertide Breakthrough Therapy Designation for the treatment of erythrocytosis in patients with polycythemia vera, a blood disease.
The company said the designation, intended to expedite development and review of promising treatments, was based on results from a phase 3 trial. The designation also sets the drug candidate up for priority New Drug Application review, the company said.
Rusfertide is being co-developed with Takeda Pharmaceuticals (TAK), though Protagonist is primarily responsible for its development through its NDA filing.
Protagonist said the company intends to submit an NDA for rusfertide in Q4.
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