The future of Ipsen’s new $1.3B drug is in doubt as safety fears force the FDA to slam the brakes on late-stage studies
Just 9 months after buying Clementia for $1.3 billion to acquire its lead rare disease drug palovarotene, the FDA has forced Ipsen to slam the brakes on treating children in late-stage studies underway for the therapy.
Officially this is a partial hold, says Paris-based Ipsen, as the feds are ordering a halt to dosing of patients 14 and under in Phase II trials and a Phase III study for fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO). But all of the patients in the MO study are limited to 14 and below, so all dosing will stop there.
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