Ipsen to pause dosing patients in the global Phase III (PVO-1A-301) study to evaluate the efficacy and safety of palovarotene in patients with fibrodysplasia ossificans progressiva.
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Ipsen announced that the FDA Prescription Drug User Fee Act (PDUFA) goal date, for the resubmitted New Drug Application (NDA) for investigational Sohonos (palovarotene) as a potential treatment for fibrodysplasia ossificans progressiva (FOP), is 16 August 2023.
The FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application for Sohonos (palovarotene), an investigational treatment from Clementia Pharmaceuticals for the reduction of new abnormal bone formation (heterotopic ossification) in people living with fibrodysplasia ossificans progressiva (FOP).
Ipsen announced that its New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARy 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).