Posted by Michael Wonder on 24 Dec 2022
Ipsen receives complete response letter for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva
23 December 2022 - The letter is related to the US FDA’s previous request for additional information on palovarotene clinical trial data.
The US FDA has issued a complete response letter regarding the new drug application for palovarotene, an investigational treatment for the reduction of new abnormal bone formation (heterotopic ossification) in people living with fibrodysplasia ossificans progressiva.
