NDA accepted for filing by the FDA for antisense oligonucleotide viltolarsen

Nippon Shinyaku

7 February 2020 - Nippon Shinyaku announced today that the U.S. FDA has accepted the filing of our new drug application under the priority review for viltolarsen in patients with Duchenne muscular dystrophy who are amenable to exon 53 skipping therapy. 

In addition to priority review, the FDA previously granted viltolarsen with fast track, orphan drug and rare disease designations.

The viltolarsen NDA includes results from a Phase 2 study and its long-term extension study in North America -- as well as a Phase 1 and a Phase 1/2 study in Japan.

Read Nippon Shinyaku press release

Michael Wonder

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Michael Wonder