Ipsen Reports the Withdrawal of NDA for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva
Shots:
- The withdrawal follows the recent discussion with the US FDA regarding the palovarotene’s NDA review that initiated in May’21
- The additional analysis will be required to progress and complete the review process from Ipsen’s P- III MOVE and FOP program. Ipsen plans to resubmit to the FDA- following completion of the required data
- Palovarotene (PO) is a selective RARγ agonist for the prevention of heterotropic ossification in patients with FOP. The FDA grants Priority Review with an anticipated PDUFA date as Nov 30- 2021
| Ref: Businesswire | Image: Ipsen
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