Ipsen’s 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) – was accepted by the U.S. Food and Drug Administration.
Ipsen’s decision to pause dosing in studies of palovarotene trials for patients with fibrodysplasia ossificans progressive (FOP) resulted in the France-based company taking a €669 million ($728 million) partial impairment from the setback.
Regeneron Pharmaceuticals Inc. said on Thursday the company’s experimental treatment for a very rare genetic bone disorder showed a nearly 90 percent reduction in new lesions compared to placebo, in a mid-stage study.
