FDA accepts Sarepta’s application to convert AMONDYS 45 and VYONDYS 53 from accelerated to full approval

Proposed text:  CureDuchenne was an early funder of Sarepta Therapeutics, and we are pleased to share that the US FDA has accepted supplemental New Drug Applications (sNDAs) for AMONDYS 45 and VYONDYS 53, for individuals with Duchenne amenable to skipping exon 45 and exon 53, respectively.  The FDA is targeting a PDUFA decision date of February 28, 2027.  If successful, this would convert the accelerated approvals of these two drugs to traditional approvals.  Sarepta has indicated that these applications include data from the ESSENCE confirmatory study, published real-world evidence, and considerable safety data.   

Press release:  https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-announces-fda-acceptance-sndas-amondys-45r-and-vyondys