Posted by Michael Wonder on 29 May 2021
Ipsen confirms U.S. FDA accepts new drug application for palovarotene as the first potential treatment worldwide for fibrodysplasia ossificans progressiva
28 May 2021 - New drug application granted priority review status, with a decision anticipated on 30 November 2021.
Ipsen today announced that its new drug application for palovarotene, an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification as a potential treatment option for people living with the progressive disabling and ultra-rare genetic disorder fibrodysplasia ossificans progressiva, has been accepted by the U.S. FDA.
