Amondys 45 (casimersen)

Amondys 45 is not recommended for approval/coverage by Evicore because clinical benefit has not been established, despite FDA accelerated approval for treatment of Duchenne muscular dystrophy in patients with a DMD gene mutation amenable to exon 45 skipping. The FDA indication requires a confirmed exon 45–amenable DMD mutation and continued approval is contingent on confirmatory trials demonstrating clinical benefit.

"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."

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