US regulators have agreed to re-review Bristol-Myers Squibb’s application to market its investigational hepatitis C drug daclatasvir in combination with Gilead’s Sovaldi (sofosbuvir) for patients with genotype 3 forms of the disease.
The US Food and Drug Administration said it will review the submission - which now includes data from the Phase III ALLY-3 trial - within a six-month timeframe.
New clinical data show high cure rates for the daclatasvir/sofosbuvir combination, with sustained virologic response 12 weeks after treatment in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 HCV patients.
Response rates were higher - 96% - in non-cirrhotic genotype 3 patients, regardless of treatment history, the firm said, and also noted that, overall, the regimen was well-tolerated, with “no deaths, treatment-related serious adverse events, or discontinuations due to adverse events” in the trial.
B-MS says it is hoping to address a high unmet patient need that still exists despite recent hepatitis C treatment advances, given that around 9%-12% of HCV patients in the US have genotype 3 and limited treatment options.