By Pierre Bertrand
Ipsen said on Wednesday that the European Commission has decided against granting a marketing authorization for palovarotene for the treatment of fibrodysplasia ossificans progressiva.
The decision follows the negative opinion back in May by the Committee for Medicinal Products for Human Use, the company said.
Palovarotene is an investigational treatment to treat fibrodysplasia ossificans progressiva, an ultra-rare condition that continuously and permanently causes abnormal bone formation. It is the first treatment to be submitted for regulatory approval, Ipsen said.
Ipsen said it would continue to seek regulatory approval in other countries and regions.
Write to Pierre Bertrand at [email protected]
Read the full article here
