Ipsen Receives Complete Response Letter from U.S. FDA

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Decision on palovarotene capsules pushed back to 2023

Today, December 23, 2022, Ipsen shared this press release announcing that they received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) in response to its New Drug Application (NDA) for palovarotene capsules.

A CRL indicates that the FDA has conducted a complete review of the data in a new drug application (NDA) and subsequently found that it cannot approve the application in its present form.

The Ipsen press release indicates: "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."

Howard Mayer, Executive Vice President and Head of Research and Development for Ipsen emphasized Ipsen's continued commitment to the development of an approved treatment for FOP." Although this extends the review timeline for palovarotene, we continue to work with the FDA to provide the requested information and believe that investigational palovarotene has the potential to be an innovative treatment to reduce new abnormal bone formation to slow the progression of FOP.”

It's important to note that the FDA is not asking Ipsen to conduct a new clinical trial. Ipsen plans to respond during the first quarter of 2023 with data from the current studies.

The Complete Response Letter did not include a new date for the FDA Advisory Committee Meeting. The IFOPA won't seek more letters from the FOP community until a new Advisory Committee Meeting date is announced. 

Complete Response Letters are rarely made public by the product sponsors who receive them since they generally contain proprietary information and are considered trade-secret confidential regulatory correspondence by the FDA.

Thank you again to all of those living with FOP who participated in the MOVE trial. You can read the full press release here



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