Shots:
- The NDA submission is based on data from the ongoing P-III MOVE trial evaluating the efficacy and safety of palovarotene (chronic/flare-up dosing regimen) in patients with FOP
- The post hoc analyses of 1EPs from the P-III MOVE trial demonstrated a 62% reduction in mean annualized new HO volume in patients with palovarotene vs untreated participants from a natural-history study. The FDA grants Priority Review with an anticipated PDUFA date as 30 Nov 2021
- The EMA and Swissmedic have also validated the MAA for the therapy. The company anticipates additional applications to other regulatory agencies in due course
Click here to read full press release/ article | Ref: Globe Newswire | Image: Genetic Engineering and Biotechnology News
The post Ipsen Reports the US FDA’s Acceptance of NDA for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva first appeared on PharmaShots.
