This follows ongoing dialogue with the U.S. FDA regarding the palovarotene NDA review, initiated in May 2021PARIS (BUSINESS WIRE) Regulatory News:Disclaimer: Intended for international media and investor audiences onlyIpsen (Euronext: IPN; ADR: IPSEY) today announced, following very recent discussions with the U.S.
Disclaimer: Intended for international media and investor audiences only Ipsen confirms U.S. FDA accepts New Drug Application for palovarotene as the first potential treatment worldwide for fibrodysplasia ossificans progressiva (FOP) New Drug Application granted Priority Review status, with a decision anticipated on 30 November 2021 Authorization Application (MAA) for palovarotene with Swissmedic granting palovarotene a priority review PARIS, FRANCE, 28 May 2021 - Ipsen (Euronext: IPN; ADR: IPSEY) today announced that its New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification (new bone formation) as a potential treatment option for people living with the progressive disabling and ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP), has been accepted by the U.S. Food and Drug Administration (FDA). The target regu
New Drug Application granted Priority Review status, with a decision anticipated on 30 November 2021 European Medicines Agency (EMA) and Swissmedic have also validated the Marketing Authorization