MYLAN together with New Avakash have launched a new drug called Tenofovir alafenamide (TAF) meant to assist first liners on ARV treatment in Zimbabwe.
Tenofovir alafenamide (TAF) is a nucleotide reverse transcriptase inhibitor (NtRTI), an antiretroviral drug being investigated for HIV-1 infection and chronic hepatitis B.
The antiretroviral (ARV) ,Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS.
Mylan is the world’s largest producer of HIV/AIDS drugs, and more than 40% of people being treated worldwide for HIV/AIDS depend on a Mylan antiretroviral product.
Mylan has committed itself again and again to bringing new therapeutic options to people living with HIV as quickly as possible and to as many people as possible
“The launch of Mylan’s Dolutegravir, Emtricitabine, and Tenofovir Alafenamide tablets sets a new standard for affordable access for patients in countries hardest hit by HIV, as it’s the first time a product combines dolutegravir and tenofovir alafenamide,” said Mylan Business Head Mr Sateesh Jami.
“With limited funding, the world needs cost competitive and clinically effective products like this one, and New Avakash is proud to work with partners to make it available and help reach the more than 15 million people living with HIV worldwide who still need access to treatment,” Dr Tadesse Mekonen, executive director Health Care Services , Research and Development and Education Programs at Avacare Health Group said.
Mylan’s ARV is a once-daily, fixed-dose combination of Dolutegravir, Emtricitabine and Tenofovir Alafenamide, the individual components that make up ViiV Healthcare’s Tivicay and Gilead’s Descovy.
Mylan manufactures these products under licenses from the Medicines Patent Pool and Gilead Sciences, respectively.
The combination of these agents is currently included as a “Recommended Initial Regimen for Most People with HIV” in the HIV guidelines of the U.S. Department of Health and Human Services.
“We are proud that Mylan has been the first supplier to receive FDA approval for nearly half of the new medicines under PEPFAR since 2009. In the last year alone, we have been the first company to receive approval for three new fixed-dose combination products that use a lower dose of Efavirenz, Dolutegravir, and now Dolutegravir in combination with Tenofovir Alafenamide,” said Mylan Business Head Mr Sateesh Jami.
The tablet will be the smallest sized single-tablet regimen available for patients in the developing world. It will be offered in a 90 and 30 days packages, potentially allowing patients fewer trips to the clinics for a refill.
Mylan was also the first generic drug maker to develop a heat-stable version of a drug critical for second-line regimens, and is the leading supplier of pediatric ARVs, including taste-masked and dispersible formulations.
Minister of Health and Child Care, Obadiah Moyo applauded Mylan for being the biggest supporter of the patient community through the sponsorship of free community HIV/AIDS testing and clinical research.
During a Presentation, Asso vice president (Product Development) for Mylan Laboratories Ltd, Mr Emmanuel Patras said Mylan is a global pharmaceutical company committed to setting new standards in healthcare.
“We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend,” said Mr Emmanuel.