Viltolarsen (NS-065/NCNP-01) has completed NDA to FDA October in 2019. The NDA of Viltolarsen is applied as priority review by FDA and regulatory approval by FDA is expected in July to September, 2020. Viltolarsen is also completed J-NDA. Viltolarsen is authorized as Sakigake designation and early conditional approval system and regulatory approval in Japan is expected in March 2020.
Viltolarsen is Antisense-mediated exon skipping aiming for a promising therapeutic application for Duchenne muscular dystrophy (DMD) and It is developed by Nihonshinyaku.