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Vyondys 53 FDA Approval History

Last updated by Judith Stewart, BPharm on April 6, 2020.

FDA Approved: Yes (First approved December 12, 2019)
Brand name: Vyondys 53
Generic name: golodirsen
Dosage form: Injection
Company: Sarepta Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy

Vyondys 53 (golodirsen) is a phosphordiamidate morpholino oligimer for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.

Development timeline for Vyondys 53

DateArticle
Dec 12, 2019Approval FDA Approves Vyondys 53 (golodirsen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 53
Aug 19, 2019Sarepta Therapeutics Receives Complete Response Letter from the US Food and Drug Administration for Golodirsen New Drug Application
Feb 14, 2019Sarepta Announces FDA Acceptance of Golodirsen (SRP-4053) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
Dec 20, 2018Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
Mar 12, 2018Sarepta Therapeutics Announces Plan to Submit a New Drug Application (NDA) for Accelerated Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy (DMD) Amenable to Skipping Exon 53
Sep  6, 2017Sarepta Therapeutics Announces Positive Results in Its Study Evaluating Gene Expression, Dystrophin Production, and Dystrophin Localization in Patients with Duchenne Muscular Dystrophy (DMD) Amenable to Skipping Exon 53 Treated with Golodirsen (SRP-4053)

See also

Vyondys 53 (golodirsen) Consumer information

Further information

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