HIV Combination Drug Receives Tentative FDA Approval Under PEPFAR

The FDA yesterday granted tentative approval to dolutegravir, emtricitabine, and tenofovir alafenamide (DTG/FTC/TAF) tablets, 50-mg/200-mg/25-mg, under the US President’s Emergency Plan for AIDS Relief (PEPFAR) program, according to a Mylan press release.

Under the PEPFAR program, the antiretroviral (ARV) combination will be available in developing countries as a treatment for patients with HIV/AIDS.

Notably, more than 40% of the global HIV/AIDS population is being treated with a Mylan product, according to the release.

"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, CEO, Mylan. "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."

DTG/FTC/TAF is a once-daily combination of the individual components that make up ViiV Healthcare's Tivicay and Gilead's Descovy, according to the release. Mylan produces the fixed-dose combination under licenses from the Medicines Patent Pool and Gilead.

This is the first tentative approval granted to tenofovir alafenamide, which first gained FDA approval 2 years ago.

The combination ARVs are currently a "Recommended Initial Regimen for Most People with HIV" under guidelines issued by the Department of Health and Human Services, according to Mylan.

The treatment will be the smallest single-tablet ARV regimen for patients worldwide. Mylan noted DTG/FTC/TAF will be offered in a 30- and 90-day packages, which may allow patients to visit the clinic less, according to Mylan.

"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 three new fixed-dose combination products that use a lower dose of efavirenz, dolutegravir, and now dolutegravir in combination with tenofovir alafenamide."