Santhera Pharmaceuticals (SIX:SANN, OTC:SPHDF, FRA:S3F0) told investors it has received approval from Swissmedic for AGAMREE (vamorolone) for the treatment of Duchenne muscular dystrophy in patients aged four years and older.
The company expects to launch AGAMREE in Switzerland in the second half of 2026, following completion of pricing and reimbursement procedures. AGAMREE has been granted a 15-year market exclusivity under Swiss orphan drug status.
“As a proudly Switzerland-based business, securing Swissmedic approval represents an important achievement, and marks our seventh global marketing approval," said chief executive Dario Eklund.
"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 approval was based on results from the Phase 2b VISION-DMD study and data reviewed by the European Medicines Agency. In the trial, AGAMREE met the primary endpoint and showed good safety and tolerability.
AGAMREE is designed to reduce steroid-associated toxicity. Unlike corticosteroids, the product showed no restriction of growth and no negative impact on bone metabolism.