hepatitis

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Bristol-Myers Squibb‘s investigational DCV Dual Regimen (daclatasvir (DCV) and asunaprevir (ASV)) for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV).

The designation is based on data secured from the company’s ongoing Phase III clinical study programme that is evaluating the all-oral combination regimen of DCV, an investigational NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin.

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Designation is expected to speed-up the development and review of the therapy for hepatitis C treatment.

Bristol-Myers Squibb senior vice-president of global development and medical affairs, research and development Brian Daniels said: "This is an important milestone for Bristol-Myers Squibb as we continue our strategic focus on the development of innovative medicines to address areas of high unmet medical need, where potential expedited review can make a critical difference for patients."

"This is an important milestone for Bristol-Myers Squibb as we continue our strategic focus on the development of innovative medicines to address areas of high unmet medical need, where potential expedited review can make a critical difference for patients."

New data from the company’s ongoing Phase III clinical programme evaluating the DCV Dual Regimen is expected to be released in the future.

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The company said that data from other daclatasvir and asunaprevir Phase III trial in Japanese patients with HCV genotype 1b, who were either interferon-ineligible/intolerant or non-responders (null and partial) to interferon-based therapies, served as the basis for a regulatory filing in Japan in October 2013.

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Recently, the European Medicines Agency (EMA) validated the company’s marketing authorisation application (MAA) for the use of daclatasvir to treat adults with HCV with compensated liver disease, including genotypes 1, 2, 3, and 4.

The MAA seeks the approval of daclatasvir for use in combination with other agents for the treatment of chronic hepatitis C, will be reviewed under an accelerated regulatory review.

Around 170 million people worldwide are infected with hepatitis C, with an estimated 2.7 million to 3.9 million chronically infected in the US.

Image: Hepatitis C is a virus that infects the liver. Photo: courtesy of freedigitalphotos.net.