Antisense Therapeutics (ASX:ANP) says it has received notification that the European Medicines Agency Committee for Orphan Medicinal Products has adopted a positive opinion on its submission for Orphan Drug designation on ATL1102 for duchenne muscular dystrophy.
DMD is a rare and fatal genetic muscle-wasting disease where chronic inflammation in the muscle leads to fibrosis and death of muscle tissue.
Orphan drug designation in the European Union is granted based on a positive opinion issued by the European Medicines Agency Committee for Orphan Medicinal Products. The European Medicines Agency has forwarded the opinion to the European Commission for its decision on the recommendation.
This follows the granting of Orphan Drug designation for ATL1102 in DMD by the US FDA.
According to managing director and CEO Mark Diamond, “We are very pleased to receive this positive opinion on Orphan Drug designation by the EMA. Europe is a key market for the Company, particularly as we advance our planning for the conduct of a Phase IIb clinical trial with the EMA and European national regulatory authorities. We look forward to hearing from the EC in due course and to updating the market on this very significant value adding event.”