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

  Ref: Globe Newswire | Image: Genetic Engineering and Biotechnology News