Breakthrough Therapy Designation Expanded for Hepatitis C Drug Combination

The FDA today amended its breakthrough therapy designation for an experimental hepatitis C drug combination.

The FDA today amended its breakthrough therapy designation for an experimental hepatitis C drug combination.

Based on favorable results of the ALLY-1 trial, the FDA is now considering approval for daclatasvir (Daklinza) and sofosbuvir (Solvaldi) in patients with hepatitis C infections who have either advanced cirrhosis or infections that returned after a liver transplant. The combination is taken once a day in combination with ribavirin for 12 weeks.

The results of the trial, which were presented last month at the 2015 International Liver Congress in Vienna, showed the drug combination was effective in patients with hepatitis C viral genotype 1 with advanced liver disease.

It was originally granted breakthrough therapy designation by the FDA in 2013, and the agency is also reviewing a new drug application for daclatasvir and sofosbuvir for the treatment of patients with HCV genotype 3.

Daclatasvir was approved in Europe in August 2014 as part of a combination therapy regimen for hepatitis C genotypes 1, 2, 3, and 4 in adults. It has also been approved in Japan, regions of Latin America and South America, the Middle East, and Asia.