Posted by Michael Wonder on 20 Dec 2016
Sarepta Therapeutics announces EMA validation of eteplirsen authorisation application for treatment of Duchenne muscular dystrophy amenable to exon skipping 51
19 December 2016 - Sarepta Therapeutics today announced that the EMA validated the previously submitted marketing authorisation application for eteplirsen to treat Duchenne muscular dystrophy amenable to exon 51 skipping.
Sarepta is seeking conditional approval of eteplirsen in the EU through the centralized procedure. Validation of the application confirms that the submission is accepted and starts the formal review process by the EMA’s CHMP. The standard review period is 210 days (plus additional time for applicant to respond to questions from the agency).
