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news.The US Food and Drug Administration (FDA) has accepted for review Bristol-Myers Squibb's (BMS) resubmitted new drug application (NDA) for its investigational NS5A replication complex inhibitor, daclatasvir, for use in combination with sofosbuvir to treat chronic hepatitis C (HCV) genotype 3.
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The company said that the original NDA has been amended to include data from the Phase III ALLY-3 trial, which tested a 12-week, ribavirin-free regimen and resulted in sustained virologic response (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 HCV patients.
HCV genotype 3 is estimated to affect around 54.3 million people across the world, and is the second most common hepatitis C genotype after genotype 1 that affects about 83.4 million people.
The open-label Phase III clinical trial enrolled 152 genotype 3 HCV patients including 101 treatment-naïve and 51 treatment-experienced patients in two groups and they each received daclatasvir 60mg and sofosbuvir 400mg once daily for 12 weeks, with 24 weeks of follow-up.
Bristol-Myers Squibb head of Specialty Development Douglas Manion said: "The daclatasvir-based NDA seeks to address a high-unmet patient need that still exists despite recent hepatitis C treatment advances. Approximately 9-12% of HCV patients in the US have genotype 3.
"That’s thousands of individuals in the U.S. who historically have had limited treatment options requiring at least 24 weeks of treatment.
"We also are continuing clinical trials to determine the potential of daclatasvir-based regimens in treating a range of other high unmet-need patients, including those coinfected with HIV, HCV patients with decompensated cirrhosis, and HCV recurrence in post-transplant patients."
In this Phase III trial, the daclatasvir and sofosbuvir combination regimen was well tolerated and there were no deaths, treatment-related serious adverse events, or discontinuations due to adverse events.