(CercleFinance.com) – Ipsen announces that the US FDA has granted priority review to the application for approval of the investigational drug palovarotene for the treatment of patients with fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disease.
The expected date of regulatory action assigned by the FDA under the Prescription Drug User Fee Act (PDUFA) is December 29, 2022, which is within regulatory submission deadlines.
FDA ‘Priority Review’ designation is given to investigational therapies that, if approved, represent a significant improvement in the safety or effectiveness of the treatment over the current standard of care.
With an estimated prevalence of 1.36 per million individuals, FOP is characterized by new extra-skeletal bone formation, particularly in the soft connective tissues, which leads to loss of mobility and reduced life expectancy.
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