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поиск по ресурсному центру The drug was approved in India in November this year and is the “first” to be approved in eight years for the management of this infection here, Mylan added.
US drugmaker Mylan hopes to capture a “major” share of the Rs 140-crore market for chronic Hepatitis B with the launch of its once-daily tablet for this infection in adults. The drug will have a maximum retail price of Rs 1,900 ($29,5) for a pack of 30 tablets, said the company’s India and emerging markets president.
The drug was approved in India in November this year and is the “first” to be approved in eight years for the management of this infection here, Mylan added.
The company said its latest launch, 25mg tenofovir alafenamide (TAF) tablet branded ‘HepBestTM’, demonstrates “comparable” efficacy to the earlier tenofovir disoproxil fumarate (TDF) drug and has an “enhanced” renal and bone safety profile.
The last drug approved in India for chronic Hepatitis B was TDF in 2009, according to Rakesh Bamzai, President, India and Emerging Markets, Mylan.
“TAF would take a major share of the new patients that come on treatment for chronic Hepatitis B,” he told ET.
India has an estimated 40 million Hepatitis B virus (HBV) carriers, of which 15% to 25% could go on to suffer from cirrhosis and liver cancer, he said. Current treatment options available include tenofovir & entecavir and there are multiple brands in this segment, he added.
There is presently no cure for Hepatitis B infection and treatment is long-term, said Bamzai.
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, the firm stated in its release.
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. These patients are at risk of developing serious illness and death, largely resulting from liver cirrhosis and liver cancer, Mylan stated.
