Sarepta’s Duchenne Muscular Dystrophy Therapy Wins FDA Approval
- Posted by ISPE Boston
- On March 10, 2021
The FDA has approved Sarepta Therapeutics Amondys 45, an antisense oligonucleotide, for the treatment of Duchenne muscular dystrophy (DMD) in certain patients. Consistent with the accelerated approval pathway, the continued approval of Amondys 45 may be contingent on confirmation of a clinical benefit in confirmatory trials. The Essence trial – a placebo-controlled confirmatory trial to […]
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