Mylan receives tentative approval for combination HIV treatment DTG/FTC/TAF under FDA’s PEPFAR program.
Global pharmaceutical company Mylan N.V. received 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 the world’s largest producer of HIV/AIDS drugs, and more than 40 percent of people being treated worldwide for HIV/AIDS depend on a Mylan antiretroviral product.
“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. “With limited funding, the world needs cost competitive and clinically effective products like this one, and Mylan 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.”
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.
This is the first tentative approval of tenofovir alafenamide and comes just two years after the FDA approval of Descovy. 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.
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.
(Source: Mylan N.V.)
Filed Under: Drug Discovery