EU recommends PrEP in Gilead’s HIV prevention treatment
pharmafile | July 25, 2016 | News story | Research and Development, Sales and Marketing | EU, Gilead, HIV, PrEP, prevention
Gilead has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency, on the combination of Truvada (emtricitabine/tenofovir disoproxil) and safer sex practices to reduce the risk of sexually acquired HIV-1 infection.
This strategy, aimed at adults at high risk of contracting the infection, is known as pre-exposure prophylaxis, of PrEP. Advocates have described PrEP as one of the most effective ways at reducing the risk of developing HIV among high risk groups.
Gilead had submitted a type II variation application for Truvada, which was approved in the EU in 2005. This application was based on two large placebo-controlled trials of the drug for PrEP, which were sponsored by the US National Institutes of Health and the University of Washington, respectively.
The drug is currently approved for PrEP in the US, Canada and South Africa, among others. The European Commission will now decide whether or not to approve Truvada in this indication.
Professor Jean-Michel Molina, from the University of Paris 7, says: “The CHMP’s opinion moves the medical community closer to being able to offer an additional HIV prevention tool to people at high risk of HIV acquisition across the entire EU.
“Evidence supports pre-exposure prophylaxis, in combination with safer sex practices, to reduce the risk of sexually acquired HIV and we look forward to the potential public health impact of PrEP, in addition to increasing access to testing and universal treatment of people living with the disease, in helping to lower HIV transmission rates in Europe.”
Sean Murray
Related Content
Gilead’s HIV treatment meets primary trial endpoint
Gilead has announced positive topline results from its phase 3 ARTISTRY-2 trial, which evaluated a …
Gilead announces first shipments of HIV prevention drug to Eswatini and Zambia
Gilead has announced the first shipments of its HIV prevention drug lenacapavir to Eswatini and …
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
