FDA Tentatively Approves Fixed-Dose HIV Combo Therapy

The US Food and Drug Administration (FDA), under the US President's Emergency Plan for AIDS Relief (PEPFAR), has granted tentative approval of a New Drug Application (NDA) for a once-daily, fixed-dose combination of dolutegravir, emtricitabine, and tenofovir alafenamide, in tablet form doses of 50 mg/200 mg/25 mg for the treatment of HIV/AIDS.

Approval was granted to Mylan NV, and the antiretroviral therapy (ART) will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS. The combination therapy agents are currently included as "Recommended Initial Regimen for Most People with HIV" in the HIV guidelines of the US Department of Health and Human Services.

This is the first tentative approval of tenofovir alafenamide, coming just 2 years after the FDA approved Gilead Sciences' combination treatment of emtricitabine and tenofovir alafenamide.

"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," Heather Bresch, Mylan's CEO, said in a statement. "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."

The once-daily, fixed-dose combination consists of dolutegravir (Tivicay, ViiV Healthcare) and emtricitabine and tenofovir alafenamide (Descovy, Gilead Sciences). According to Mylan, the company manufactures the products under acquired licenses from the Medicines Patent Pool and Gilead Sciences, respectively.

The tablet will be the smallest sized single-tablet regimen available for patients in the developing world, according to Mylan. The company intends to offer the therapy in 90-day and 30-day packages.

Additionally, ViiV Healthcare recently announced that it is conducting a phase 3 clinical trial in order to determine if adults with HIV-1 who have achieved viral suppression on a triple-drug regimen (consisting of tenofovir alafenamide fumarate (TAF)) could maintain such suppression on a duo-therapy regimen of dolutegravir and lamivudine. As patients with HIV struggle with adherence to a daily-pill regimen, manufacturers continue to search for ways to adjust patients' regimens to increase adherence and address those challeneges.

"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," Rajiv Malik, the president of Mylan, said in a statement. "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."

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