Posted by Michael Wonder on 19 Aug 2021
EMA validates Gilead’s marketing authorisation application for lenacapavir, an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options
19 August 2021 - EMA MAA validation follows submission of NDA for Lenacapavir to the U.S. FDA.
Gilead Sciences today announced that the company’s marketing authorisation application for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the EMA.
The proposed indication is for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations.
