Ipsen banking on post-hoc analyses in palovarotene bid

Mid-size French drugmaker Ipsen (Euronext: IPN) is hoping to be lucky third time around in its bid to gain US Food and Drug Administration (FDA) approval for palovarotene for the prevention of heterotopic ossification in patients with fibrodysplasia ossificans progressiva (FOP).

Ipsen withdrew its first filing in 2021 after it was discovered that there were issues with the imaging vendor that required image re-read and re-analysis of data for the primary endpoint.

The firm then received a complete response letter from the FDA late last year, in response to the company’s second submission. The agency demanded further information on the submitted trial data on Phase II and Phase III studies, the latter of which failed to meet its prespecified primary efficacy analysis on annualized new heterotopic ossification volume.