FDA issues Complete Response to application for Sohonos in fibrodysplasia ossificans progressiva.- Clementia Pharmaceuticals
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).
The CRL is related to the regulatory agency’s previous request for additional information on palovarotene clinical trial data communicated to Ipsen in October 2022, which is not a request for additional efficacy or safety data beyond existing studies. Ipsen anticipates responding to the request in the first quarter of 2023 with an expected six-month FDA review cycle. The FDA has not announced a rescheduled date for the Endocrinologic and Metabolic Drugs Advisory Committee meeting for investigational palovarotene.
The company states that although this extends the review timeline for palovarotene, it will continue to work with the FDA to provide the requested information and believes that investigational palovarotene has the potential to be an innovative treatment to reduce new abnormal bone formation to slow the progression of FOP.
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