Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.
For more information on how to use this blog click here, the HCV drug pipeline click here, and for more information on HCV clinical trials click here
Drugs in Development / Clinical Trials—Updated March 17, 2015
Friday, March 27, 2015
The product will be available to Indian patients shortly, the Bangalore-based company said in a statement.
"In September 2014, Strides entered into a licensing agreement with Gilead Sciences Inc to bring Hepatitis C cure to 91 developing countries," Strides Arcolab said in a statement.
Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Sovaldi® (sofosbuvir) for the Treatment of Genotype 2 Chronic Hepatitis C
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 26, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Sovaldi® (sofosbuvir), a once-daily nucleotide analog polymerase inhibitor, for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis. Sovaldi is indicated for use in combination with ribavirin (RBV) for 12 weeks. Sovaldi (in combination with RBV) is the first all-oral, interferon-free treatment regimen for genotype 2 HCV infection. Sovaldi is also the first product to be marketed by Gilead in Japan.
“Today’s approval represents an important step forward in the management of hepatitis C in Japan, enabling genotype 2 infected patients the opportunity of a cure in 12 weeks with an all-oral regimen that eliminates the need for interferon,” said Masao Omata, MD, Yamanashi Prefectural Hospital Organization.
Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than one million people chronically infected with HCV, 20-30 percent have the genotype 2 strain of the virus. Currently approved therapies in Japan for genotype 2 HCV infection involve 24-48 weeks of injections with pegylated interferon, which may not be suitable for many patients.
Sovaldi’s approval is supported by data from a Phase 3 clinical trial conducted in Japan (Study GS-US-334-0118) among treatment-naïve and treatment-experienced genotype 2 patients. Approval was based on 96 percent (n=135/140) of genotype 2 HCV-infected patients who received 12 weeks of an all-oral regimen of Sovaldi plus RBV 600–1,000 mg/day achieving a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. The approval is also supported by SVR12 results from four international Phase 3 studies (FISSION, FUSION, POSITRON and VALENCE), which included genotype 2 HCV patients.
“There is a need in Japan for new HCV treatment options that are more effective and better tolerated and we have been pleased to partner with the medical community here in Japan to demonstrate the efficacy and safety of Sovaldi,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We look forward to making Sovaldi available in Japan as quickly as possible, while simultaneously continuing to work with the agency on its review of our second application for an all-oral sofosbuvir-based regimen for the treatment of genotype 1 HCV infection.”
Gilead filed a New Drug Application (NDA) in Japan for a single-tablet regimen of sofosbuvir and the NS5A inhibitor ledipasvir for the treatment of genotype 1 HCV infected patients on September 24, 2014. The ledipasvir/sofosbuvir single tablet regimen is an investigational product in Japan and its safety and efficacy have not yet been established.
- See more at: http://gilead.com/news/press-releases/2015/3/japans-ministry-of-health-labour-and-welfare-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-genotype-2-chronic-hepatitis-c#sthash.tfSV7EEB.dpuf