Mylan bags FDA’s tentative approval for fixed-dose HIV combo therapy

The approval of the company’s New Drug Application (NDA) was granted under the US President's Emergency Plan for AIDS Relief (PEPFAR).

Following the approval, Mylan said that it will immediately launch the antiretroviral (ARV) therapy in developing countries as a first-line regimen for people being treated for HIV/AIDS.

The approved ARV is indicated to be taken daily once as per the fixed dosage. It combines Dolutegravir, and Emtricitabine and Tenofovir Alafenamide, which in turn are the individual drugs that constitute ViiV Healthcare's Tivicay and Gilead Sciences' Descovy, respectively.

Mylan CEO Heather Bresch said: "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.

"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."

According to Mylan, the DTG/FTC/TAF tablet will be smallest sized single-tablet regimen to be made available for patients in developing countries. The company will launch DTG/FTC/TAF in 90-day and 30-day packages, which would potentially lower the trips of patients to the clinics for a refill.

Mylan president Rajiv Malik said: "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.

"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."

Earlier this month, Mylan launched Efavirenz Tablets USP, 600mg, a generic version of Bristol-Myers Squibb's Sustiva in the US. The product is indicated to be used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in both adults and pediatric patients.

Image: FDA Building 51 in Silver Spring, Maryland which houses the Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.