FDA Accepts Combination Hepatitis C Treatment Application for Review


The agency is slated to review the new drug application within a 6-month timeframe.

The FDA has accepted Bristol-Myers Squibb’s resubmitted new drug application (NDA) for the approval of daclatasvir, an investigational hepatitis C virus (HCV) genotype 3 treatment for use in combination with sofosbuvir.

“The daclatasvir-based NDA seeks to address a high-unmet patient need that still exists despite recent hepatitis C treatment advances,” said Douglas Manion, head of Specialty Development at Bristol-Myers Squibb, in a press release. “Approximately 9% to 12% of HCV patients in the US have genotype 3. That’s thousands of individuals in the US who historically have had limited treatment options requiring at least 24 weeks of treatment.”

Bristol-Myers Squibb amended its original NDA with data from the phase 3 ALLY-3 trial, which showed sustained virologic response in 90% of the 101 treatment-naïve and 86% of the 51 treatment-experienced genotype 3 HCV patients who received the once-daily daclatasvir 60 mg and sofosbuvir 400 mg combination regimen.

The regimen was well tolerated in the study, with no reported deaths, treatment-related serious adverse events, or treatment discontinuations due to adverse events. However, there were 17 treatment failures, and the most frequent side effects were headache, fatigue, nausea, diarrhea, insomnia, abdominal pain, and arthralgia.

Manion mentioned that Bristol-Myers Squibb is also clinically testing the potential of daclatasvir-based regimens in patients co-infected with HIV, HCV patients with decompensated cirrhosis, and HCV recurrence in post-transplant patients.

Daclatasvir, a NS5A replication complex inhibitor, has already been approved for use in Europe and Brazil in combination with other drugs across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults. It is also currently used in Japan in combination with asunaprevir, a NS3/4A protease inhibitor.

The FDA is slated to review the NDA within a 6-month timeframe.

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