BMS resubmits new drug application for Daklinza

Bristol-Myers Squibb has resubmitted a new drug application to the FDA for Daklinza, a NS5A replication complex inhibitor, intended to treat hepatitis C virus infection genotype 3, according to a news release from the drug maker.

The new drug application (NDA) for Daklinza (daclatasvir, Bristol-Myers Squibb), which is intended for use in combination with Sovaldi (sofosbuvir, Gilead Sciences), has been amended to include data from the ALLY-3 study, which were presented at The Liver Meeting 2014 in Boston. The FDA has accepted the new application for review, according to the release.

“The daclatasvir-based NDA seeks to address a high-unmet patient need that still exists despite recent hepatitis C treatment advances,” Douglas Manion, MD, head of specialty development at BMS, said in the release. “Approximately 9% to 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. 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 November 2014, the FDA submitted a letter to Bristol-Myers Squibb requesting more information on daclatasvir, since the original application focused on a daclatasvir/asunaprevir combination. Bristol-Myers Squibb withdrew the new drug application for asunaprevir, an NS3/4A protease inhibitor, in October 2014.

Daclatasvir was approved in Europe in August 2014, and more recently in Brazil in January 2015, for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults, according to the release. Daclatasvir was also approved in Japan in combination with asunaprevir, a NS3/4A protease inhibitor, in June 2014.