Posted by Michael Wonder on 23 Sep 2018
Sarepta receives negative CHMP re-examination opinion for eteplirsen
21 September 2018 - Relying upon Scientific Advisory Group input, Sarepta will seek further scientific advice from European Medicines Agency on a possible path to bring eteplirsen to patients in Europe.
Sarepta Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has confirmed its 31 May 2018 negative opinion for a Conditional Marketing Application for eteplirsen. Eteplirsen is designed to treat approximately 13% of the Duchenne muscular dystrophy community who have genetic mutations amenable to exon 51 skipping.
The Company expects the European Commission (EC) to adopt the CHMP opinion by year-end 2018.
