BRIEF—FDA postpones palovarotene AdCom

The US Food and Drug Administration (FDA) has today announced its decision to postpone the planned Endocrinologic and Metabolic Drugs Advisory Committee meeting for investigational palovarotene until a later date to be confirmed, says the drug’s developer, French drugmaker Ipsen.

The original advisory committee meeting was scheduled for October 31, 2022.

Ipsen has had a number of setbacks in gaining regulatory clearance for its fibrodysplasia ossificans progressiva (FOP) treatment, which finally gained its first approval in Canada, under the trade name Sohonos, in January this year.

The FDA informed Ipsen that the postponement relates to an FDA request for new information on palovarotene clinical trial data and does not relate to the safety profile of palovarotene.

The company says it is currently working to fulfil the request.