AMT Receives Orphan Drug Designation for DMD Treatment
- Posted on 22 October 2009
Amsterdam Molecular Therapeutics (AMT) has announced that the European Medicines Agency (EMEA) has granted Orphan Drug Designation to the former’s gene therapy product AMT-080 for the treatment of Duchenne Muscular Dystrophy (DMD).
Orphan Drug Designation for DMD entitles AMT to ten year market exclusivity in Europe following marketing approval for AMT-080 if this product candidate is the first new drug with a major medical benefit receiving marketing approval for the European Union.
The designation also provides for special benefits, including research support, eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development or at the time of application for marketing approval.
