Mylan launches first approved drug for chronic Hepatitis B infection
Rupali Mukherjee | TNN | Dec 7, 2017, 19:47 IST
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MUMBAI: Mylan Pharmaceuticals launched HepBest 25 mg (tenofovir alafenamide, TAF), a once-daily tablet for the treatment of chronic hepatitis B in adults. HepBest (TAF) is the first drug in eight years to be approved for the management of chronic hepatitis B in India, says a company statement.
Natco and Hetero are also in the process of launching the drug, industry sources say. The drug TAF demonstrates comparable efficacy, with an enhanced renal and bone safety profile as compared to earlier formulation of tenofovir (tenofovir disoproxil fumarate)
According to World Health Organization (WHO) estimates, over 2 billion people worldwide are infected with hepatitis B virus (HBV), of which over 240 million have chronic liver infection.
The cost of treatment for 'HepBest' will be Rs 1900 per month, the product is available in pack of 30s. Going forward with economies of scale, the prices are expected to come down like it has been the case for Tenofovir and Entecavir, a company spokesperson said.
These patients are at risk of developing serious illness and death, largely resulting from liver cirrhosis and liver cancer. TAF demonstrates comparable efficacy with an enhanced renal and bone safety profile as compared to the earlier formulation of tenofovir (tenofovir disoproxil fumarate). TAF also has greater plasma stability, which ensures efficient drug delivery to the site of action.
Commenting on the launch, Rakesh Bamzai, president, India and emerging markets said, "India has an estimated 40 million HBV carriers, of which 15% to 25% could go on to suffer from cirrhosis and liver cancer. Mylan continues to be in the forefront of introducing new treatment regimens for the management of hepatitis in India".
In 2014, Mylan 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. 作者: StephenW 时间: 2017-12-8 09:10