Matrix Laboratories Limited, an Indian subsidiary of Mylan has received tentative approval from the US Food and Drug Administration (FDA) for a new once-daily combination of three antiretrovirals to combat HIV/AIDS.
The approval, granted under the President’s Emergency Plan for AIDS Relief (PEPFAR), is for the first-ever combination of efavirenz, lamivudine and tenofovir disoproxil fumarate.
The product may be used in adults as either a first-line or second-line treatment after patients have developed resistance to initially prescribed treatments.
Mylan president Heather Bresch said that by combining three antiretroviral (ARV) products into a once-daily dose, the quality of care for people living with HIV/AIDS in emerging markets can dramatically be improved.
“Lower pill burden also increases the likelihood that patients adhere to treatment,” Bresch said.
The FDA’s tentative approval means that Matrix’s product meets all of the agency’s manufacturing quality, safety and efficacy standards.
The product will be available for purchase in developing countries outside of the US only due to existing patents that prevent its marketing in the US.