BRIEF—Rival to Sarepta submits NDA for DMD drug

Japanese company Nippon Shinyaku has completed the submission of its rolling New Drug Application (NDA) to the US Food and Drug Administration (FDA) for viltolarsen, which is under development for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping.

The news comes six weeks after the FDA rejected Sarepta Therapeutics’ NDA for Vyondys 53 (golodirsen) in this group of patients.

Nippon Shinyaku has also submitted its NDA for viltolarsen, which has US Fast Track Designation, to the Ministry of Health, Labor and Welfare in Japan.