reuters.com

US FDA Approves Regeneron's Pasatru for Rare Bone Disorder FOP

Regeneron Pharmaceuticals logoRegeneron Pharmaceuticals
Sig2.75Sen+6.60Env0.00Soc+6.10Gov+1.30

Regeneron’s garetosmab drug Pasatru was approved by the US FDA to treat adults with fibrodysplasia ossificans progressiva. In a 56-week trial of 63 participants, it reduced new bone abnormalities by 94% with a 3 mg/kg dose and by 90% with a 10 mg/kg dose versus placebo by blocking Activin A. The company plans a children’s trial later this year, after earlier study pauses and redesign with regulators. Pasatru will compete with Ipsen’s Sohonos.

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