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news.Bristol-Myers Squibb (BMS) has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Daklinza (daclatasvir) and Sunvepra (asunaprevir), as a new treatment that can lead to cure for many patients with genotype 1 chronic hepatitis C virus (HCV) infection in Japan.
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Daklinza is a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), while Sunvepra is a NS3/4A protease inhibitor.
Currently there are no treatment options for this disease in Japan, and the combination drug is the country’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis.
Hiroshima University lead study investigator Kazuaki Chayama said Japan has a unique hepatitis C patient population, many of whom are older and have been unable to take, or respond to, traditional therapies, so we have a real sense of urgency to treat these patients now.
"The approval of the Daklinza+Sunvepra Dual Regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV patients," Chayama said.
Bristol-Myers Squibb chief executive officer Lamberto Andreotti said the approval of Daklinza+Sunvepra in Japan reflects the company’s strategic focus on developing a treatment option that meets the needs of the Japanese HCV patient population.
"This milestone underscores the company’s commitment to delivering innovative medicines to patients with the highest unmet needs, and we believe Daklinza-based regimens will play a significant role in the evolution of HCV treatment for patients in Japan, and globally," Andreotti said.
In Japan, the indications for the combination drug are for the improvement of viraemia in either of the following patients with chronic hepatitis C genotype 1, or chronic hepatitis C genotype 1 with compensated cirrhosis: patients who are ineligible or intolerant to interferon-based therapy, and patients who have failed to respond to interferon-based therapy.
The approval is based on results from a Phase III trial showing that the 24-week regimen of Daklinza and Sunvepra achieved overall SVR24 (sustained virologic response 24 weeks after the end of treatment; a functional cure) among 84.7% of Japanese HCV patients with genotype 1b.
Image: A Bristol-Myers Squibb R&D facility in Princeton Rd, Princeton, New Jersey, US. Photo: courtesy of Coolcaesar