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# Ipsen NDA Resubmission for Palovarotene
- URL: https://www.fdaweb.com/ipsen-nda-resubmission-for-palovarotene/
- Published: 2023-03-17T12:00:00.000Z
- Updated: 2026-09-14T18:20:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154012

FDA has accepted for review an Ipsen resubmitted NDA for palovarotene as a potential treatment for fibrodysplasia ossificans progressiva (FOP). The ultra-rare disease causes permanent and continuous bone formation in soft and connective tissues like muscles, tendons and ligaments. The agency has set a user fee review action date of 8/16.

The company says its submission contains additional clinical trial data that was requested in a 12/2022 complete response letter. It also includes additional analyses from across the palovarotene clinical trial program, including the pivotal MOVE study, a Phase 3 study carried out in people with FOP.

In late October, FDA postponed a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting that was scheduled to review palovarotene. The company says the agency has not announced a new date for the panel meeting.