Exondys

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eteplirsen

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 31 May 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Exondys, intended for the treatment of Duchenne muscular dystrophy. The company that applied for authorisation, AVI Biopharma International Ltd, requested a re-examination of the CHMP's opinion on 1 June 2018.

After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 20 September 2018.

This EPAR was last updated on 12/12/2018

Application details

Product details
Name
Exondys
Active substance
eteplirsen
International non-proprietary name (INN) or common name
eteplirsen
Therapeutic area (MeSH)
Muscular Dystrophy, Duchenne
Anatomical therapeutic chemical (ATC) code
M09AX
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Application details
Marketing-authorisation applicant
AVI Biopharma International Ltd
Date of opinion
20/09/2018
Date of refusal of marketing authorisation
06/12/2018

Assessment history

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