Santhera Pharmaceuticals (SANN.SW,SPHDF) announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved AGAMREE (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients aged four years and older.
The approval by Swissmedic was supported by data from the pivotal Phase 2b VISION-DMD study, along with assessment results from the European Medicines Agency. This regulatory milestone marks a significant advancement in addressing the needs of patients living with DMD.
Following the approval, Santhera has been granted a 15-year exclusivity period under Swiss orphan drug status. The company retains exclusive distribution rights for AGAMREE in Switzerland and plans to initiate commercial launch in the second half of 2026, pending completion of national pricing and reimbursement procedures.
Currently, more than 200 individuals in Switzerland are affected by DMD, with limited treatment options available. The approval of AGAMREE offers new hope for patients and families impacted by this rare and debilitating disease.
SANN.SW closed on January 14 at CHF 13.26, down CHF 0.62 or 4.47%.
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