FDA places partial clinical hold on studies of Ipsen’s palovarotene

The FDA has instituted a partial clinical hold on four studies evaluating Ipsen’s (OTCPK:IPSEY) palovarotene due to a potential safety signal in patients under the age of 14. Specifically, there have been reports of early growth plate closure in patients with fibrodysplasia ossificans progressiva (FOP), a rare disorder characterized by the gradual replacement of tendons and ligaments with bone, who were treated with the RARγ agonist.

The affected trials are two Phase 2 studies in FOP (PVO-1A-204 and PVO-1A-202), one Phase 2 in osteochondroma (PVO-2A-201) and one Phase 3 in FOP.

Treatment of patients in the osteochondroma study will be suspended since it primarily involves children up to the age of 14.

Participants in the FOP studies older than 14 will continue receiving treatment.

Recruitment of new patients below the age of 14 will be suspended in all four trials.

Palovarotene is the lead drug developed at Clementia Pharmaceuticals, acquired by Ipsen in April for up to $1.3B.

https://seekingalpha.com/news/3524373-fda-places-partial-clinical-hold-on-studies-of-ipsens-palovarotene