U.S. FDA Approves Expanded Use of Daklinza

U.S. FDA Approves Expanded Use of DaklinzaIn the U.S., Daklinza (daclatasvir) plus Sovaldi (sofosbuvir), a FDA approved hepatitis C treatment for those with hep C genotype 3, is now also FDA approved to treat hep C genotype 1 or 3 patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of hep C. The treatment is approved to be prescribed on its own or combined with ribavirin.

See yesterday’s press release for more information about the FDA approval, suggested treatment lengths, and clinical trial results for Daklinza and Sovaldi.

“The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb, in the company’s press release.

Daklinza in Canada

In Canada, Daklinza was approved for use with Sovaldi last August. Daklinza with Sovaldi, when prescribed in Canada, is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free, treatment for patients with chronic hep C genotype 1, 2, or 3, who have or don’t have liver cirrhosis. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 90% of the patients who have been treated with Daklinza and Sovaldi.