This morning, Sarepta announced that following its request for re-examination, the Committee for Human Medicinal Products (CHMP) in Europe issued a negative opinion for eteplirsen. 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.

Read here the official press release by Sarepta.

The EMA states on his meeting highlights from the CHMP 17-29 September 2018 that “The applicant for Exondys (eteplirsen) requested a re-examination of the Committee’s negative opinion for this medicine adopted at the May 2018 meeting. After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed its previous recommendation to refuse the granting of a marketing authorisation for this medicine.”