FDA Tentatively OKs Fixed-Dose HIV Combo Therapy – APhA submits compounding comments to FDA. – (866) 348-2889
Officials with the FDA have 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.
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.