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