The EMA’s human medicines committee delivered a negative opinion on palovarotene, making it very unlikely that the drug will be approved by the European Commission, although Ipsen says it will be requesting a re-examination of the marketing application.
The decision comes after Ipsen was forced to withdraw its marketing application for palovarotene in the US in 2021, which delayed regulatory filings elsewhere, although the French pharma company has picked up an approval for the drug in Canada, where it is sold as Sohonos.
