Mylan Launches HepBestTM, First Drug Approved in Eight Years for Management of Chronic Hepatitis B Infection in India
On December 07, 2017, Mylan Pharmaceuticals Private Limited announced that it has launched HepBest" 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. These patients are at risk of developing serious illness and death, largely resulting from liver cirrhosis and liver cancer. HepBest" (TAF) is the first drug in eight years to be approved for the management of chronic hepatitis B in India10.
Compared to the earlier formulation of tenofovir (tenofovir disoproxil fumarate), TAF demonstrates not only comparable efficacy but also an enhanced renal and bone safety profile. TAF also has greater plasma stability, which ensures efficient drug delivery to the site of action.
In 2014, Mylan signed an agreement with Gilead to increase access to TAF-based HIV treatments in developing countries. As part of the licensing agreement, on U.S. Food and Drug Administration (FDA) approval, Mylan received a technology transfer from Gilead, enabling it to manufacture low-cost versions of TAF.
Earlier in November 2017, Indian Drug Regulator, CDSCO approved Tenofovir Alafenamide Fumarate bulk & 25 mg capsules11. Tenofovir Alafenamide Fumarate bulk & 25 mg capsules are indicated for the treatment of chronic Hepatitis B virus infection in adults with compensated liver disease.
Mylan Labs presented the data on the drug including data from global clinical trials conducted, in which India was a participating country. The data presented shows that Tenofovir Alafenamide and TDF are equivalent in terms of efficacy but Tenofovir Alafenamide has reduced toxicity. The data was presented on June 14, 2017, before the CDSCO's advisory committee of Antimicrobial & Antiviral.
After review of the data, the committee considered the request for waiver of local clinical trial and recommended for conduct of the BE study as per the protocol submitted12.
Tenofovir Alafenamide is a nucleotide reverse transcriptase inhibitor and a prodrug of tenofovir. It was developed by Gilead Sciences for use in the treatment of HIV infection and chronic hepatitis B, and is applied in the form of tenofovir alafenamide fumarate (TAF).
Footnotes
10 http://www.mylan.in/en/news/press-releases/2016/mylan-launches-hepbest-in-india
11 http://www.cdsco.nic.in/forms/list.aspx?lid=2034&Id=11
12
http://www.cdsco.nic.in/writereaddata/MOM%20of%20SEC%20Antimicrobial
%20and%20Antiviral%20 14_06_2017%20(Website)%20(1).pdf
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