Update as of 21 May 2024
The European Commission has asked the CHMP to review its January opinion on the renewal of the marketing authorisation for Translarna. The CHMP will now consider the Commission’s request, including the additional real-world data brought to the attention of the Commission during the decision-making process.
In addition, as part of this review EMA will take into account the impact of the appellate judgment of the Court of Justice of the European Union in Case C-291/22 P.
EMA will communicate further on 31 May 2024 as part of the CHMP Highlights…
