Bristol-Myers Squibb’s Resubmitted Application for its Hepatitis C Drug Accepted by the FDA

The US Food and Drug Administration (FDA) has accepted for review Bristol-Myers Squibb’s (BMS) resubmitted application for its investigational hepatitis C drug.

The company said that the agency accepted its New Drug Application (NDA) for daclatasvir, an investigational NS5A replication complex inhibitor, for use in combination with Gilead’s sofosbuvir for the treatment of patients with chronic hepatitis C (HCV) genotype 3.

Last year, BMS was forced to withdraw its initial request for approval. Now, the company’s amended application includes data from the late-stage ALLY-3 trial, which showed that the combination regimen cured 90 percent of treatment-naïve patients and 86 percent of patients who failed previous therapies 12 weeks after treatment (SVR12). In non-cirrhotic genotype 3 patients, regardless of treatment history, SVR12 rates were 96 percent.

In the Phase III study, the daclatasvir and sofosbuvir combination regimen was well tolerated, with no deaths, treatment-related serious adverse events, or discontinuations due to adverse events. The most common side effects included headache, fatigue, nausea, diarrhea, insomnia, abdominal pain and arthralgia. Additionally, there were 17 treatment failures, with 16 relapses post-treatment and 1 rebound at the end of treatment.

The company said that the agency will review the company’s application within a six-month timeframe.

Genotype 3 is the second most common strain of HCV, following genotype 1. HCV genotype 3 is estimated to affect 54.3 million people worldwide. The more aggressive nature of genotype 3 lies in the damage it causes to the liver, as it is associated with progressive disease, increased rate of steatosis and a disproportionately increased risk of hepatocellular carcinoma.

“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 U.S. 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,” said Douglas Manion, MD, head of Specialty Development, Bristol-Myers Squibb. “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.”

Source: Bristol-Myers Squibb

Last updated: 3/13/15; 3:10pm EST


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