Mylan Pharmaceutical, a subsidiary of Mylan N.V., on Thursday, a day ahead of World Hepatitis Day announced the launch of Velpatasvir 100 mg/Sofosbuvir 400 mg tablets under the brand name MyHep All in India. MyHep All is a fixed-dose combination tablet for the treatment of chronic Hepatitis C virus (HCV) infection in adults, including all six major HCV genotypes, said a company statement. A Velpatasvir 100 mg/Sofosbuvir 400 mg combination product is currently sold by Gilead Sciences in other markets under the brand name EPCLUSA. HCV is a bloodborne virus commonly transmitted through unsafe injection practices, inadequate sterilisation of medical equipment and the transfusion of unscreened blood and blood products. HCV also can be transmitted sexually and can be passed from an infected mother to her baby.
It's estimated that over 70 million people around the world have chronic Hepatitis C infection and nearly 400,000 people die each year from Hepatitis C-related liver diseases. "Chronic Hepatitis C is a significant public health burden in India. When we launched Mylan's Hepato Care division in January 2015, we did so to increase access to critical, life-saving medicines for patients with chronic HCV and other liver-related conditions," said Mylan President Rajiv Malik.
"The launch of the fixed-dose combination of MyHep All is part of this mission and will help patients adhere to their chronic HCV treatment regimen," he added. The MyHep All launch follows Mylan's successful January 2016 launch of MyHep LVIR (Ledipasvir/Sofosbuvir combination) in India.
Mylan has the non-exclusive right to manufacture and distribute Velpatasvir/Sofosbuvir in approximately 100 developing countries via a license agreement from Gilead Sciences.