NDA accepted for filing by the FDA for antisense oligonucleotide Viltolarsen
NS Pharma announced the FDA has filed a New Drug Application (NDA) for their antisense oligonucleotide drug NS-065/NCNP-01 (viltolarsen). Viltolarsen is a drug candidate that hopes to treat people with Duchenne who have a mutation in the DMD gene amenable to exon 53 skipping. 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.
