The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed Ipsen's investigational drug palovarotene the week of January 23. The review was based on results of the Phase III Move Trial.
The CHMP has recommended the EMA NOT grant marketing authorization (i.e. approval) for palovarotene as a treatment for FOP. Ipsen has announced this news in a press release and noted that they are requesting a re-examination from the EMA. This means that Ipsen's work to seek approval in the EU is not over.
Thank you again to all of those living with FOP who participated in the MOVE trial.
Questions? Please send an email to [email protected]