Mylan launches tablets for treatment of Hepatitis C in India

HERTFORDSHIRE, England and PITTSBURGH: Mylan Pharmaceuticals Private Limited (a subsidiary of Mylan N.V.) 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 indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, including all six major HCV genotypes.

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 sterilization 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.

HCV can cause both acute and chronic infections. Approximately 55–85% of those infected will develop chronic HCV infection. People with chronic HCV infection are often undiagnosed because the infection can remain asymptomatic for decades. In many instances, symptoms develop because of serious liver damage.

It's estimated that more than 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," commented 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. Mylan has a longstanding, ongoing commitment to accelerate access and to improve treatment outcomes in India and other developing countries."

The MyHepAll™ 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.