Ipsen Announces FDA Priority Review For Palovarotene NDA In Patients With Rare Genetic Disorder

(RTTNews) - The U.S. Food and Drug Administration has accepted for Priority Review Ipsen's (IPSEY) resubmitted New Drug Application or NDA for investigational palovarotene for the treatment of patients with fibrodysplasia ossificans progressiva or FOP, an ultra-rare genetic disorder.

Ipsen is seeking approval of palovarotene, an oral, selective retinoic-acid receptor gamma (RAR?) agonist for the prevention of heterotopic ossification.

The FDA has assigned 29 December 2022 as the Prescription Drug User Fee Act goal date, which is on track with anticipated regulatory submission timelines.

Palovarotene is an oral investigational, selective retinoic-acid receptor gamma (RAR?) agonist being developed as a potential treatment for people living with the debilitating ultra-rare genetic disorder fibrodysplasia ossificans progressiva.

Palovarotene, which received rare pediatric disease and Breakthrough Therapy Designations from the U.S. Food and Drug Administration for the potential treatment of FOP, was acquired by Ipsen through the acquisition of Clementia Pharmaceuticals in April 2019.

The palovarotene New Drug Application was initially accepted by the FDA for Priority Review on May 28, 2021, and Ipsen announced withdrawal of the NDA on August 13, 2021.