Ipsen: CHMP Recommends Not To Grant Marketing Authorization For Palovarotene As Treatment For FOP

By RTTNews Staff Writer ✉ | Published: 1/27/2023 1:13 AM ET

Ipsen (IPSEY) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended not to grant marketing authorization for investigational palovarotene as a treatment for the ultra-rare bone disease, fibrodysplasia ossificans progressiva. The CHMP opinion is based on its review of data from MOVE, the first and largest Phase III efficacy and safety trial conducted in fibrodysplasia ossificans progressiva.

Ipsen said it will be requesting a re-examination of the CHMP opinion, based on scientific data available from the existing palovarotene clinical trial program.

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