Logo

Ipsen Reports the Withdrawal of NDA for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva

Share this

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

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions