FDA Accepts BMS’ NDA for HCV Drug Daclatasvir
Bristol-Myers Squibb reports that the US Food and Drug Administration has accepted for review its resubmitted new drug application (NDA) for daclatasvir, an investigational NS5A replication complex inhibitor, for use in combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3. Sofosbuvir is the active ingredient in Gilead Sciences’ HCV drug, Sovaldi.
The original NDA was 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-naÃ¯ve 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 time frame.
Genotype 3 is estimated to affect 54.3 million people worldwide, and is the second most common hepatitis C genotype after genotype 1 (83.4 million). The more aggressive nature of genotype 3 lies in the damage it causes to the liver, as it is associated with progressive disease, increased rates of steatosis,and a disproportionately increased risk of hepatocellular carcinoma.
Daclatasvir was approved in Europe in August 2014, and more recently in Brazil in January 2015, for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. Daclatasvir also is approved in Japan in combination with asunaprevir, a NS3/4A protease inhibitor. The daclatasvir + asunaprevir dual regimen is an all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis.
Source: Bristol-Myers Squibb