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All Eyes On US Approval After Ipsen’s FOP Candidate Rejected By EU

Second Time Lucky?

 
• By Ayisha Sharma

The French firm’s palovarotene for fibrodysplasia ossificans progressiva received a thumbs down from the European Commission, but a positive advisory committee outcome on the other side of the pond bodes well for its second attempt at US approval.  

red cross graphic in hand
The EU Has Rejected The Drug After A CHMP Negative Opinion • Source: Shutterstock
Key Takeaways

  • The rejection follows on from a negative CHMP opinion issued in January.

After a controversial clinical development path, Ipsen SA’s palovarotene has been rejected in the EU for the treatment of the ultra-rare bone disorder fibrodysplasia ossificans progressiva (FOP), but an upcoming decision in the US could yield a better outcome given recent events.

FOP causes permanent new bone formation in the soft and connective tissues, a process known as heterotopic ossification (HO). The...

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