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
Click here to read full press release/ article | Ref: Businesswire | Image: Ipsen
The post Ipsen Reports the Withdrawal of NDA for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva first appeared on PharmaShots.
