Breaking News from Ipsen Regarding their US FDA Submission for Palovarotene

Today, August 13, it was announced by Ipsen that the US Food & Drug Administration (FDA), as part of its regulatory review of palovarotene's New Drug Application (NDA), has asked for additional analyses and evaluation of data collected from Ipsen’s Phase III MOVE and FOP program.

As was announced in May 2021, the FDA had accepted Ipsen's regulatory submission package and announced a Prescription Drug User Fee ACT (PDUFA) date of November 30, 2021. PDUFA dates serve as approximate dates when a final decision on drug approval can be expected. 

From Ipsen's press release...
It was agreed between Ipsen and the FDA that it would not be possible to complete this (additional analyses) within the current NDA review cycle. As a result, Ipsen has therefore confirmed their withdrawal of the NDA for palovarotene. After recent discussion with FDA, Ipsen plans to resubmit to the FDA upon completion of the additional data analyses.

While there is likely disappointment that a decision won't be made by the FDA in November, it is reassuring to know that Ipsen plans to resubmit the NDA after the additional analyses is complete. Voluntary withdrawal of an NDA application will allow Ipsen and the FDA to restart their discussions where they left off. Alternatively, a "decline" of the NDA would restart the entire review process potentially taking the agency longer to arrive at a final decision.

Review of palovarotene by other regulatory authorities around the globe continues as was announced in May 2021. Ipsen has been granted fast-track review by Swissmedic and standard review by the European Medicines Agency (EMA). Swissmedic fast-track review is 140 days. The EMA standard review timeline is 12 months. A new announcement is that Ipsen has been granted priority review by Health Canada with a review timeline of 215 days.

It is also important to note that this change does NOT impact Ipsen's work on IPN60130 (the drug formerly developed by Blueprint Medicines); it is an entirely separate drug development program. IPN60130 has completed a Phase I trial in healthy humans and plans for a Phase II clinical trial are under development.

If you were a participant in the MOVE trial and have additional questions, please contact your Study Coordinator.

Read the full Ipsen press relase 
Read a community letter from Ipsen leadership

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