CHMP recommendations include Truvada for PrEP

EMA's CHMP backed approval of a host of drugs on Friday, and recommended expanding the label of HIV therapy Truvada emtricitabine/tenofovir disoproxil fumarate from Gilead Sciences Inc. (NASDAQ:GILD) to include pre-exposure prophylaxis (PrEP).

The committee backed Truvada's use in combination with safer sex practices for PrEP to reduce the risk of sexually acquired HIV-1 in adults at high risk. FDA approved Truvada for PrEP in 2012. It is a fixed-dose combination of the nucleoside analog reverse transcriptase inhibitors (NRTI) emtricitabine and tenofovir. ...