Gilead Sciences, Inc. (NASDAQ:GILD) now has marketing authorization from the European Commission for one-daily Truvada.
Once-daily Truvada is meant to be used by adults at high risk of infection, in combination with safer-sex practices. The aim is to reduce the risk of acquiring HIV-1 infection.
The prevention strategy is called pre-exposure prophylaxis, or PrEP.
While there has been significant process in the treatment of HIV, infection rates are still rising and European healthcare professionals are looking for an answer.
“In 2014, we saw the highest number of newly diagnosed cases in the European Union ever recorded, with 94% of those with known cause transmitted through sexual contact,” said Professor Jean-Michel Molina, representing the Hôpital Saint Louis in Paris and University of Paris 7.
“Truvada for PrEP provides an additional prevention tool, which when used with safer-sex practices, will help uninfected adults at high risk of HIV protect themselves against the virus,” he added.
The drug is already the most prescribed antiretroviral medicine in Europe as part of a combination therapy.
“The approval of Truvada for PrEP represents an important step forward in addressing the incidence of HIV in Europe” said Gilead Sciences Executive Vice President of Research and Development and chief scientific officer Norbert W. Bischofberger.
“When taken as directed and used in combination with other prevention strategies, Gilead believes Truvada for PrEP can have a meaningful impact on public health by helping to reduce HIV transmission rates across Europe,” he added.
The European Medicines Agency approved Truvada in 2005 for use in combination with other retroviral agents for treatment of HIV-1 infection in adults 18 years and older.
The new authorization from the European Commission lets Gilead market Truvada for PreP throughout the European Union, though still subject to national regulatory approval in each of the 28 member countries.
Truvada is also authorized for PrEP in Australia, Canada, Kenya, Peru.
Gilead shares were down on Monday by 0.18% at $80.85.