Bristol-Myers' Daklinza-Sovaldi Expanded by FDA for Treatment of Chronic Hep C

Source: Zacks Equity Research

Feb 09, 2016

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administraion (FDA) has expanded the use of Daklinza, in combination with Gilead Sciences Inc.'s Sovaldi, for the treatment of patients with chronic hepatitis C (HCV) genotype 1 or 3.

According to Zacks Equity Research, the Daklinza-Sovaldi combination can now be used with or without Ribavirin to treat three new patient populations: chronic HCV patients with HIV-1 coinfection, patients with advanced cirrhosis and patients with post-liver transplant recurrence of HCV. 

In July 2014, the FDA approved the Daklinza-Sovaldi combination for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection. 

In August 2014, the Daklinza-Sovaldi combination was also approved in the European Union (EU) for the treatment of genotype 3 HCV patients without cirrhosis. Additionally, Daklinza is approved in the EU in combination with other medicinal products for the treatment of adults with chronic HCV infection across genotypes 1, 2, 3 and 4. 

Drugs currently approved for the treatment of HCV include Harvoni, Viekira Pak, Olysio and Sovaldi among others, said Zacks Equity Research. 

Read the full article here.