FDA Approved: EXONDYS 51 — Original Application (Sarepta Therapeutics, Inc.)

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Summary

FDA approved Exondys 51 (eteplirsen) from Sarepta Therapeutics as the original NDA for Duchenne muscular dystrophy amenable to exon 51 skipping.

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Diseases / indications

• Duchenne Muscular Dystrophy

Drugs mentioned

• EXONDYS 51 (eteplirsen)

Snippet

ORIG AP for EXONDYS 51 (ETEPLIRSEN)