IPSEN has issued a press release announcing that they have honored their commitment to refile with the US Food & Drug Administration (FDA) in Q1 of 2023. Additional information on palovarotene clinical trial data, requested in a complete response letter to IPSEN in December 2022, will be reviewed by the FDA as part of this resubmission process.
In response, the FDA has assigned a new PDUFA Date (i.e. decision date) of August 16, 2023. This is the date by which the FDA will make a decision on palovarotene capsules as a treatment for FOP. If it is approved, the decision will include a label which defines who can be prescribed the drug when it is commercially available.
Also of note in the press release: IPSEN has requested a re-examination of the European Medicines Agency’s January 2023 Committee for Medicinal Products for Human Use (CHMP) opinion on palovarotene. This is in response to the negative opinion issued by the CHMP in January.
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