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Sarepta Therapeutics: FDA Approval of AMONDYS 45™ (casimersen)

February 25, 2021

Sarepta Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has approved the Amondys 45 (casimersen) for patients amenable to skipping exon 45. This extends their commercial reach to approximately 30% of all Duchenne muscular dystrophy patients.

“This is an important day for Sarepta and, far more importantly, for the patients that we serve. After years of scientific commitment, investment and development, the approval of AMONDYS 45, Sarepta’s third approved RNA therapy, offers treatment to the 8% of the DMD community who have a confirmed exon 45 amenable mutation.”

“Along with our other approved RNA therapies, we can now offer treatment options for nearly 30% of Duchenne patients in the U.S. And our commitment to bring therapies to the greatest percentage of the DMD community as soon as possible continues.”

“Decades of research and commitment have fueled and now accelerate our progress towards new treatments for Duchenne,” said Marissa Penrod, founder of Team Joseph and parent of an 18-year old with Duchenne. “The extraordinary diligence and persistence of the Duchenne community – patients and families, clinicians and researchers – have led us to today’s approval, where we now have exon-skipping treatments for almost a third of those with Duchenne.”

Doug Ingram, president and chief executive officer, Sarepta

Click here to read the full press release.