Kept on hold at the FDA, Ipsen scraps a key trial and revamps R&D path for its troubled $1B-plus rare disease drug
After getting slammed by a partial hold on safety fears and flunking a futility test, Ipsen says it has decided to revamp its R&D plans for their troubled development program for palovarotene, scrapping a sidelined study while revising its trial analysis in hopes of capturing positive data.
The French biotech, which acquired the drug in their $1 billion-plus Clementia buyout, paused a Phase III and Phase II trial following the futility analysis. Earlier, the FDA had imposed a hold on dosing patients under the age of 14 after seeing evidence that the drug designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth.
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