Halloween adcomm postponed as FDA seeks more Ipsen data on ultra rare disorder drug candidate
In a new setback for Paris-based Ipsen, the FDA is postponing an adcomm meeting that was set for Oct. 31 to review new information on the company’s previously spurned potential treatment of patients with fibrodysplasia ossificans progressiva, an ultra-rare genetic disorder.
The FDA said the postponement is “to allow time for the FDA to review new information,” while Ipsen said “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 is currently working to fulfill the request.”
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