Bristol-Myers’ daclatasvir NDA resubmission accepted by FDA

US pharma major Bristol-Myers Squibb (NYSE:BMY) says that its resubmitted New Drug Application for daclatasvir (proposed trade name Daklinza), an investigational NS5A replication complex inhibitor, has been accepted for review by the US Food and Drug Administration for use in combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3.

The original NDA has been amended to include data from the Phase III ALLY-3 trial, which showed high cure rates for the combination, with sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 HCV patients. SVR12 rates were higher (96%) in non-cirrhotic genotype 3 patients, regardless of treatment history. The FDA will now review the submission within a six-month timeframe. Sofosbuvir is the active ingredient of Gilead Sciences’ (Nasdaq: GILD) blockbuster hepatitis C treatment Sovaldi and also contained in the firm’s more recently approved combination product Harvoni (ledipasvir and sofosbuvir).

Resubmission due to withdrawal of asunaprevir’s NDA