Tentative FDA approval for 'TLE400' under PEPFAR

The US Food and Drug Administration under the US President's Emergency Plan for AIDS Relief (PEPFAR) has approved the New Drug Application for efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 400mg/300mg/300mg ("TLE400").

TLE400, an antiretroviral (ARV) fixed-dose combination from Netherlands-incorporated Mylan (Nasdaq: MYL), will be available in developing countries as a first-line regimen for people being treated for HIV/AIDS. The company previously said it expects to make TLE400 availabe at $99 per patient per year..

Mylan's TLE400 is formulated with a 400mg dose of efavirenz, which is less than the standard dose of 600mg. The Kirby Institute's ENCORE1 trial, which used drugs provided by Mylan and Gilead Sciences (Nasdaq: GILD), showed that a reduced dose of 400mg efavirenz is non-inferior to a dose of 600mg, when combined with tenofovir and emtricitabine during 48 weeks in ART-naive adults with HIV-1 infection. TLE400 was recommended by the World Health Organization in 2016 as an alternative for first-line therapy for adults living with HIV.