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Further Analyses To Delay Ipsen’s Palovarotene Progress In Ultra-Rare Disease

Withdraws US Marketing Submission

 
• By John Davis

Ipsen has withdrawn the US NDA for palovarotene in an ultra-rare bone condition in order to conduct additional data analyses, but intends to resubmit once they are complete.  

Paris Better Picture
• Source: Alamy

Ipsen SA’s plans to grow its rare disease activities have been set back by its decision to withdraw the US marketing application for palovarotene, which is being developed for the treatment of the ultra-rare bone disorder, fibrodysplasia ossificans progressive (FOP). 

The condition is associated with heterotrophic ossification, the formation of new bone in muscles, tendons and soft tissue, that progresses to

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