Ipsen’s palovarotene clinical program in fibrodysplasia ossificans progressiva reaches prespecified interim analysis futility criteria
IPSEN SA S/ADR (IPSEY)
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Source: Business Wire
Ipsen has decided to pause dosing in the palovarotene trials Based on encouraging therapeutic activity signals observed in preliminary post-hoc analyses and recommendations from the Independent Data Monitoring Committee, Ipsen to conduct further assessment of the complete data set and work with the regulatory authorities to determine the path forward PARIS--(BUSINESS WIRE)--Regulatory News:Ipsen (Euronext: IPN; ADR: IPSEY) today announced the decision to pause dosing patients in the global Phase III (PVO-1A-301) study designed to evaluate the efficacy and safety of palovarotene in patients with fibrodysplasia ossificans progressiva (FOP), as well as the ongoing Phase II (PVO-1A-202/204) extension studies. In both the Phase III and Phase II extension studies, palovarotene is dosed both chronically (daily) and episodically (during flare-ups). The decision to pause dosing patients in the trial is based on results of a futility analysis reviewed by the Independent Data Monitoring Commi
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