Santhera Pharmaceuticals (SIX: SANN) announces that the Swiss Agency for Therapeutic Products (Swissmedic), has approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older.

Dario Eklund, Chief Executive Officer of Santhera, commented: “As a proudly Switzerland-based business, securing Swissmedic approval represents an important achievement, and marks our seventh global marketing approval. We expect to launch AGAMREE in Switzerland later in 2026, in order to ensure timely access to this important therapy for DMD patients in the country.”

The Swissmedic approval of AGAMREE was based on the data from the pivotal Phase 2b VISION-DMD study and assessment results from the European Medicines Agency. Following approval, the Company has been granted a 15-year exclusivity period under Swiss orphan drug status. Santhera retains exclusive distribution rights for AGAMREE in Switzerland and anticipates commercial launch in H2 2026, following the completion of national pricing and reimbursement procedures. There are over 200 people affected by DMD in Switzerland, with few treatment options available to them.