Bristol-Myers Withdraws New Drug Application For Asunaprevir

(RTTNews) - Biopharmaceutical company Bristol-Myers Squibb Co. (BMY) has Tuesday withdrawn the new drug application (NDA) for asunaprevir as it has decided not to pursue U.S. Food and Drug Administration (FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the U.S.

Daclatasvir is a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and asunaprevir is a NS3/4A protease inhibitor.

Bristol-Myers Squibb has already received in July the approval from the Japanese Ministry of Health, Labor and Welfare or MHLW, for the dual regimen of daclatasvir and asunaprevir in Japan. The Japanese patients with HCV will receive the first all-oral, interferon- and ribavirin-free treatment regimen.

Bristol-Myers Squibb had gone on the develop the dual regimen to meet the distinct need of the unique Japanese hepatitis C patient population, many of whom are older and have been unable to take, or respond to, traditional therapies.

The company added that the treatment has the potential to play a major role in curing HCV patients population that is similar to Japan. In Japan, 1.2 million people are living with HCV, of which about 70 percent have genotype 1b.

In February, the U.S. FDA had granted Bristol-Myers' investigational Daclatasvir and sunaprevir Dual Regimen Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV infection.

Meanwhile, the company will continue to pursue FDA approval of daclatasvir, which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

Daclatasvir was recently approved in the European Union for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of HCV infection in adults.

The company said it believes that daclatasvir-based regimens have the potential to fill continued unmet medical need in the U.S. and elsewhere in the world.

Bristol-Myers noted that daclatasvir continues to be investigated in multiple treatment regimens and in people with co-morbidities, and is undergoing regulatory review in the U.S. and Europe.

The company added that it is looking to bring daclatasvir to patients in the U.S. and will continue to work closely with the FDA to advance the regulatory application, with the aim of bringing the investigational product to market as quickly as possible.

BMY closed Monday's regular trading session at $51.11, up $0.04 on a volume of 5.30 million shares.