DUBLIN – Ipsen SA is on track for an NDA filing for palovarotene in fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease characterized by the gradual replacement of skeletal muscle and connective tissue with bone, following an interim analysis of phase III data which indicates that the drug may have a substantial effect on the disease process.
Expectations that a phase III trial of Ipsen SA's palovarotene will miss its primary endpoint of reducing abnormal bone growth among people with a rare bone disorder led the company to pause dosing in that study and another as it evaluates next steps.
News of a partial FDA clinical hold for pediatric patients after safety reports from an ongoing trial testing palovarotene in fibrodysplasia ossificans progressiva (FOP) identified cases of early growth plate closure sent shares of Ipsen SA (Paris:IPN) falling 13.6% Friday.
