World’s largest HIV/AIDS drug-maker Mylan has received tentative approval for combination HIV treatment DTG/FTC/TAF under FDA’s PEPFAR program, the company said on Wednesday.
It announced getting the tentative approval from the U.S. Food and Drug Administration (FDA) under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. The antiretroviral (ARV) will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS.
Mylan is treating more than 40% of people worldwide for HIV/AIDS.
“The FDA’s tentative approval 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 CEO Heather Bresch, noting that more than 15 million people living with HIV worldwide still need access to treatment.
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 noted that it manufactures these products under licenses from the Medicines Patent Pool and Gilead Sciences, respectively.
Furthermore, this is the first tentative approval of Tenofovir Alafenamide and comes just two years after the FDA approval of Descovy. Mylan pointed out in its Wednesday press release that 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.
Mylan President Rajiv Malik has commented: “In the past decade, 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. We are proud that nearly half of the FDA’s tentative approvals under PEPFAR are Mylan products. 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.”
The tablet will be the smallest sized single-tablet regimen available for patients in the developing world. It will be offered in a 90-day package as well as a 30-day one, potentially allowing patients fewer trips to the clinics for a refill, the company has said in its press release.
Image: Illustration: Mylan’s blue bottle, and a sign