Mylan launches hepatitis B pill in India
New Delhi, Dec 7 : Global drug firm Mylan on Thursday launched a tablet for the treatment of chronic hepatitis B among adults, the first in eight years to be approved for the management of chronic disease in India.
As compared to the earlier formulation of tenofovir (tenofovir disoproxil fumarate), TAF was found to have better efficacy with an enhanced renal as well as bone safety profile.
TAF also has greater plasma stability, which ensures efficient drug delivery to the site of action.
"India has an estimated 40 million HBV carriers, of which 15 per cent to 25 per cent could go on to suffer from cirrhosis and liver cancer," Rakesh Bamzai, President, India and Emerging Markets said, in a statement.
"By bringing the best-in-class drug for hepatitis B management to India, Mylan hopes to provide care for chronic hepatitis B patients and improve overall management of the disease."
Over two billion people worldwide are infected with the hepatitis B virus (HBV), of which more than 240 million have chronic liver infection, according to the World Health Organization (WHO).
These patients are at risk of developing serious illness and death, largely resulting from liver cirrhosis and liver cancer.
In 2014, Mylan had signed an agreement with Gilead to enhance access to TAF-based HIV treatments in developing countries.
As part of the licensing agreement, on US Food and Drug Administration (FDA) approval, Mylan received a technology transfer from Gilead, enabling it to manufacture low-cost versions of TAF, the statement said.