Ipsen’s Sohonos had been the only FDA-approved treatment for fibrodysplasia ossificans progressiva, an ultra-rare disease affecting roughly 900 people worldwide. That changed Aug. 19 when the agency approved Regeneron’s IV infusion.
With Pasatru’s approval, FOP moves from a one-drug market to one in which physicians and patients have a choice.
The two drugs work differently. Pasatru blocks Activin A, a protein Regeneron’s chief scientific officer said plays a key role in driving abnormal bone formation in FOP, according to an Aug. 19 news release from Regeneron. Sohonos uses a different mechanism, a retinoic acid receptor agonist.
Pasatru’s phase 3 trial found that the drug reduced new bone lesions by 90% to 94% compared to placebo, with clinician-assessed flare-ups also dropping significantly. Sohonos, by comparison, showed a smaller effect on bone growth in its own trials, and FDA reviewers had raised concerns before its 2023 approval that it might even increase flare-ups compared to placebo. The two drugs have not been tested head to head, so this comparison is indirect.
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