Gilead Sciences’ Truvada accepted for EU review in new indication

Gilead Sciences' Truvada is to be assessed in Europe as a means of reducing the risk of sexually acquired HIV-1 infections among uninfected adults at high risk.

The European Medicines Agency has accepted the company's Type II variation application for the once-daily therapy to be used in combination with safer sex practices as a pre-exposure prophylaxis (PrEP) method.

Truvada was originally approved in 2005 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and is currently the most prescribed antiretroviral treatment in Europe.

A pair of large placebo-controlled trials of Truvada for PrEP have shown the promise it offers, showing its potential to help reduce new HIV infections.

Dr Norbert Bischofberger, Gilead's executive vice-president for research and development and chief scientific officer, said: "The EMA filing for Truvada for PrEP is timely, given the growing body of evidence supporting its use in preventing HIV and the interest expressed by the medical and patient advocacy communities."

Truvada was approved for PrEP in the United States in 2012 and in Kenya and South Africa in 2015, with further regulatory submissions pending in Australia, Brazil, Canada, Peru and Thailand.