NDA Accepted for Filing by the FDA for Antisense Oligonucleotide Viltolarsen (NS-065/NCNP-01) Exon 5 | SRPT Message Board Posts

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Msg  14065 of 14098  at  2/11/2020 10:37:55 PM  by

pineappleguava


NDA Accepted for Filing by the FDA for Antisense Oligonucleotide Viltolarsen (NS-065/NCNP-01) Exon 53

Feb. 7, 2020 - KYOTO, Japan and PARAMUS, NJ:
 
 
Just a portion of press release:  "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. Both the Phase 1/2 and Phase 2 studies evaluated changes in dystrophin levels and motor function across two doses (40 mg/kg and 80 mg/kg weekly dose groups).

The PDUFA date for viltolarsen is within the 3rd quarter (July-September) of 2020. The PDUFA date is the target date the FDA provides a decision on the approval of a new drug.

Viltolarsen represents one of the most extensively studied antisense therapies in DMD. Viltolarsen, if approved by the FDA, would represent a new treatment option for DMD patients amenable to exon 53 skipping in the United States." 
 


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