FDA Tentatively Approves Once-Daily, Fixed-Dose Combination HIV Treatment

The FDA has tentatively approved Mylan’s New Drug Application for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50mg/200mg/25mg, for the treatment of HIV/AIDS under the US President’s Emergency Plan for AIDS Relief (PEPFAR), according to a press release from the pharmaceutical company.

The combination of dolutegravir (Tivicay, ViiV Healthcare) and emtricitabine and tenofovir alafenamide (Descovy, Gilead) is the first tentative approval of tenofovir alafenamide, which comes just 2 years after the FDA’s approval of Gilead's emtricitabine and tenofovir alafenamide combination treatment.

The once-daily, fixed-dose combination will be immediately available in developing countries as a first-line regimen for people being treated 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 Heather Bresch, chief executive officer, Mylan, in a statement. “With limited funding, the world needs cost competitive and clinically effective products like this 1, 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.”

The tablet will be the smallest sized single-tablet regimen available for patients in the developing world, according the press release. It will be offered in 90-day and 30-day packages, which the company says will potentially allow patients fewer trips to the clinics for a refill.

“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,” said Rajiv Malik, president, Mylan. “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 3 new fixed-dose combination products that use a lower dose of Efavirenz, Dolutegravir, and now Dolutegravir in combination with Tenofovir Alafenamide.”