Regeneron Pharmaceuticals (REGN) has received approval from the US Food and Drug Administration for Pasatru to reduce new heterotopic ossification lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva, or FOP, the drugmaker said Wednesday.

FOP is an ultra-rare genetic disorder in which rogue bone formation progressively infiltrates muscles, tendons, ligaments and other connective tissues, causing loss of mobility and potentially making basic activities such as walking, eating and breathing difficult, the company said.

The approval was based on phase 3 OPTIMA trial results showing Pasatru reduced new heterotopic ossification lesions by 90% at the 10 mg per kg dose and 94% at the 3 mg per kg dose versus placebo at 56 weeks, the company said.

Clinician-assessed flare-ups fell 88% with the 10 mg/kg dose and 15% with the 3 mg per kg dose, the company said.

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