Mylan Launches HepBestTM, First Drug Approved in Eight Years
Bengaluru, India, December 7, 2017 – Mylan Pharmaceuticals Private Limited today launched HepBestTM 25 mg (tenofovir alafenamide, TAF), a once-daily tablet for the treatment of chronic hepatitis B in adults. According to World Health Organization (WHO) estimates, more than 2 billion people worldwide are infected with the hepatitis B virus (HBV), of which more than 240 million have chronic liver infection.[i] These patients are at risk of developing serious illness and death, largely resulting from liver cirrhosis and liver cancer.[ii] HepBestTM (TAF) is the first drug in eight years to be approved for the management of chronic hepatitis B in India.
Commentingon the launch, Rakesh Bamzai, President, India and Emerging Marketssaid, “India has an estimated 40 million HBV carriers, of which 15% to 25%could go on to suffer from cirrhosis and liver cancer.[iv] Mylancontinues to be in the forefront of introducing new treatment regimens for themanagement of hepatitis in India. By bringing the best-in-class drug forhepatitis B management, HepBestTM, to India, Mylan hopes to providecare for chronic hepatitis B patients and improve overall management of thedisease.”
In 2014,Mylan signed an agreement with Gilead to enhance access to TAF-based HIVtreatments in developing countries. As part of the licensing agreement, on U.S.Food and Drug Administration (FDA) approval, Mylan received a technologytransfer from Gilead, enabling it to manufacture low-cost versions of TAF.