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# FDA Hits Ipsen with Complete Response on Palovarotene
- URL: https://www.fdaweb.com/fda-hits-ipsen-with-complete-response-on-palovarotene/
- Published: 2023-01-06T12:00:00.000Z
- Updated: 2026-09-14T18:11:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153454

FDA has issued Ipsen Biopharmaceuticals a complete response letter on its NDA for palovarotene, an investigational treatment for reducing new abnormal bone formation (heterotopic ossification) in people living with 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 letter reiterates a 10/22 request for additional information related to palovarotene’s clinical trial data, the company says. It expects to respond to the data request before 3/31.

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.