This approval grants seven years of US market exclusivity to Mobius, once its new drug application is approved.
Ed Timm, president of Mobius, said: “Orphan drug status is a designation granted by the FDA to motivate innovation in therapies which might normally be unprofitable endeavors due to the limited occurrence of a specific medical condition. In addition to the market exclusivity, millions of dollars associated with filing fees and pediatric studies in our NDA are now waived, allowing us to focus our resources on achieving our projected milestones and commercialization.”