The drug received orphan drug status by the European Medicines Agency (EMA) in December 2008.
SMT C1100 is a small molecule drug that increases (upregulating) production of a similar, naturally occurring protein called utrophin to replace the missing dystrophin.
Summit Executive Chairman Barry Price said the approval recognizes the drug’s efficacy in the treatment of DMD.
"Our clinical candidate has now been granted orphan drug status both in Europe and the US, and this status will provide additional regulatory support and various commercial benefits including extended periods of market exclusivity," Price added.