Posted by Michael Wonder on 02 Oct 2019
U.S. FDA submission of new drug application for NS-065/NCNP-01 (viltolarsen)
2 October 2019 - Nippon Shinyaku announced that it has completed the submission of its rolling new drug application to the U.S. FDA for NS-065/NCNP-01 (viltolarsen), which is under development for the treatment of Duchenne muscular dystrophy amenable to exon 53 skipping.
Viltolarsen was granted a rare paediatric disease designation, orphan drug designation, and fast track designation in the U.S., and "SAKIGAKE designation" and “Orphan drug designation” in Japan.
Nippon Shinyaku has announced that it has submitted its NDA to the Ministry of Health, Labour and Welfare on 26 September 2019.
