Posted by Michael Wonder on 20 Nov 2016
CHMP recommends renewal of Translarna's marketing authorisation for nonsense mutation Duchenne muscular dystrophy based on continued positive benefit-risk assessment
11 November 2016 - PTC to conduct a post-authorisation clinical trial.
PTC Therapeutics today announced that the CHMP of the EMA has recommended the renewal of the conditional marketing authorisation of Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients five years and older. In connection with the renewal, the marketing authorisation will include a specific obligation to conduct an additional long-term post-authorisation trial.
The CHMP opinion forms the basis for a European Commission decision on the renewal of the marketing authorisation. The European Commission generally delivers its decision within three months.
