Gilead and Johnson & Johnson get EU backing for HIV drugs Eviplera and Edurant, respectively

In the first of two pieces of good news for HIV/AIDS drug developers, US biotech firm Gilead Sciences (Nasdaq: GILD) has received European Commission marketing authorization for Eviplera (emtricitabine/rilpivirine/tenofovir disoproxil), a complete once-daily single-tablet regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL.

“As people with HIV are living and remaining on treatment longer, the availability of new simplified therapeutic options has become even more critical,” said Mark Nelson, Service Director for the HIV Directorate, Chelsea and Westminster Hospital, London, UK. “Eviplera has the potential to be an important new treatment option for patients starting HIV therapy because it streamlines an effective HIV treatment regimen into a single daily tablet,” he added.

Eviplera combines Gilead’s Truvada, a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine 200mg and tenofovir disoproxil 245 mg, and US health care major Johnson & Johnson (NYSE: JNJ) subsidiary Tibotec Pharmaceuticals’ rilpivirine 25mg, marketed by Janssen-Cilag International (also a J&J company) as Edurant.