Posted by Michael Wonder on 16 Mar 2023
Ipsen receives new FDA PDUFA date for investigational palovarotene for the treatment of people with FOP
16 March 2023 - Ipsen today announced that the US FDA PDUFA goal date, for the resubmitted new drug application for investigational palovarotene as a potential treatment for fibrodysplasia ossificans progressiva, is 16 August 2023.
Additional information on palovarotene clinical trial data, requested in a complete response letter to Ipsen in December 2022, will be reviewed as part of this resubmission process.
