ARTICLE | Clinical News

Rilpivirine/emtricitabine/tenofovir alafenamide regulatory update

September 21, 2015 7:00 AM UTC

Gilead said EMA accepted for review an MAA for a single-tablet regimen combining Emtriva emtricitabine and tenofovir alafenamide plus Edurant rilpivirine from Johnson & Johnson to treat HIV-1 infection in patients ages >=12. In late July, Gilead submitted a Priority Review voucher along with an NDA to FDA for the product for the indication (see BioCentury, July 13). ...