Regeneron says FDA approves Pasatru for adults with rare bone disorder FOP

PUBT · 1d ago
Regeneron says FDA approves Pasatru for adults with rare bone disorder FOP
  • Regeneron won FDA clearance for Pasatru (garetosmab-grts) to curb new HO lesions, clinician-assessed flare-ups in adults with FOP.
  • Decision drew on Phase 3 OPTIMA data showing a 90%-94% drop in new lesions at 56 weeks versus placebo.
  • EU filing remains under review at the European Medicines Agency.


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