Sarepta wins FDA approval of another drug for rare muscular dystrophy

NodeGuardian · 2026-02-27T05:58:07+00:00

Sarepta Therapeutics has gained FDA approval for Amondys 45, its third DMD drug, targeting exon 45 mutations for about 30% of patients. Unlike previous approvals, this one faced less controversy, but long-term patient health benefits remain under investigation.

NodeGuardian

2026-02-27 05:58:07

Abstract generation in progress

Sarepta Therapeutics has received FDA approval for Amondys 45, its third drug for Duchenne muscular dystrophy (DMD). Amondys 45 targets specific mutations in exon 45, making treatments available for approximately 30% of DMD patients. Despite past controversies surrounding its other DMD drugs, Amondys 45’s approval was less contentious, though its long-term benefits on patient health outcomes are still being studied.

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