← Drug database

Exondys (eteplirsen)

Orphan
Region
🇪🇺 EU
Active substance
eteplirsen
Company
AVI Biopharma International Ltd
Status
Refused
Therapeutic area
Muscular Dystrophy, Duchenne
CHMP opinion
Thu 20 Sep 2018
Designations
Orphan
Application
EMEA/H/C/004355
ATC
M09AX
Official record
www.ema.europa.eu

Indication

Treatment of Duchenne muscular dystrophy.

Regulatory milestones

No milestones recorded in the last year.

Follow Exondys

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.