Casimersen Intravenous Infusion (Amondys 45®)

Amondys 45 (casimersen IV) is FDA‑accelerated approved for Duchenne muscular dystrophy in patients with a confirmed DMD mutation amenable to exon 45 skipping, but this policy does not recommend approval/coverage because clinical benefit has not been established. Continued FDA approval requires confirmatory trials verifying clinical benefit, and the policy specifies no additional documentation or medical‑record requirements.

"Amondys 45 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. This indication is app..."

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