drugset / Press release

Approval for TELAVIC® 250mg Tablet Novel Mode of Action for Chronic Hepatitis C Treatment

2011-09-26 · Tanabe Pharma Corporation · original tanabe-pharma.com ↗

September 26, 2011 Press Release Mitsubishi Tanabe Pharma Corporation Approval for TELAVIC® 250 mg Tablet Novel Mode of Action for Chronic Hepatitis C Treatment Osaka, Japan, September 26, 2011--- Mitsubishi Tanabe Pharma Corporation (President & CEO: Michihiro Tsuchiya) announced today that the company has received approval for the manufacturing and marketing of TELAVIC ® 250 mg Tablet (generic name: telaprevir, code name: MP-424), an antiviral chronic hepatitis C, as of September 26, 2011. TELAVIC® is an orally available antiviral agent created by Vertex Pharmaceuticals Incorporated (Cambridge, MA, U.S.A.). In Japan, the product had been developed by Mitsubishi Tanabe Pharma for the domestic market, and filed an NDA on January 26, 2011. It has been positioned as a first-in-class drug with a novel mechanism of action that suppresses proliferation of hepatitis C virus (HCV) by inhibiting NS3-4A serine protease, an enzyme that acts in the replication of HCV. The combination therapy that adds TELAVIC ® to the current standard treatment (telaprevir + pegylated interferon α-2b(recombinant) + ribavarin) showed to substantially improve treatment effectiveness and to shorten the required treatment period, compared to the current standard treatment, in domestic clinical studies for the patients with chronic hepatitis C affected by genotype 1 virus. In addition, this treatment was shown to be effective for patients that have had a recurrence after the conventional treatment and for patients for whom the conventional treatment has not been effective. Common adv erse reaction in the studies included anaemia and rash. The combination therapy with three drugs including TELAVIC® is expected to be a new treatment option for patients with chronic hepatitis C, and plays a major role in the treatment. The Company will launch TELAVIC ® soon after its registration in the NHI price listing, and endeavor to support appropriate usage properly through informing efficacy and safety of TELAVIC®. Mitsubishi Tanabe Pharma will fulfill the expectations of patients as well as medical professionals through developing and marketing pharmaceuticals that satisfy unmet medical needs, and contribute to the healthier lives of people around the world through the creation of pharmaceuticals. <<Contact for Inquiries>> Corporate Communications Department Phone: +81-6-6205-5211

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