Once-Daily Fixed-Dose HIV Combo Drug from Mylan NV Receives Tentative Approval from FDA

February 20, 2018

Mylan NV's new drug application for its combo regimen of dolutegravir, emtricitabine, and tenofovir alafenamide, received tentative approval from the US Food and Drug Administration under the President's Emergency Plan for AIDS Relief (PEPFAR).

Mylan NV has announced that is its New Drug Application (NDA) for the once-daily, fixed-dose combinations of dolutegravir, emtricitabine, and tenofovir alafenamide Tablets, 50 mg/200 mg/25 mg has received tentative approval from the US Food and Drug Administration (FDA) under the US President's Emergency Plan for AIDS Relief (PEPFAR). The antiretroviral (ARV) 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," Mylan CEO Heather Bresch is quoted as saying in a press release on the approval.

The once-daily, fixed-dose combination is made up of ViiV Healthcare's Tivicay (dolutegravir) and Gilead's Descovy (emtricitabine and tenofovir alafenamide). According to Mylan's press release, the company 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 US Department of Health and Human Services. This is the first tentative approval of tenofovir alafenamide, just 2 years after FDA approval of Gilead's combo of emtricitabine and tenofovir alafenamide.

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

As HIV patients continue to struggle with the challenge of adhering to a daily-pill regimen, manufacturers are continually looking for ways to adjust patients' regimens to enable them to take fewer pills. In addition to the approval of this single-tablet regimen, ViiV Healthcare recently announced that they are launching a phase 3 study to determine if adults with HIV-1 who have achieved viral suppression on a 3-drug regimen (consisting of tenofovir alafenamide fumarate (TAF)) could maintain this suppression when switched to a 2-drug regimen of dolutegravir and lamivudine.