European Medicines Agency

PTC Therapeutics CEO Stuart Peltz discusses next steps for ataluren, an experimental 'stop codon read-through' drug for Duchenne and Becker MD caused by specific mutations

posted on February 21, 2013 - 4:31pm
Trials of the experimental muscular dystrophy drug ataluren showed that the drug was generally well-tolerated and slowed the rate of decline in walking ability, compared to the placebo group. After consulting with regulatory agencies in Europe and the United States, biopharmaceutical company PTC Therapeutics has decided to move ahead with a global, phase 3 confirmatory study of ataluren. Trial...

The European Medicines Agency has agreed to review PTC Therapeutics’ application for conditional approval of ataluren, its experimental drug for DMD/BMD

posted on December 6, 2012 - 6:00am
Update (Dec. 6, 2012): This story has been updated with additional information about next steps for ataluren.