Try our mobile app
– EMA MAA Validation Follows Submission of NDA for Lenacapavir to the U.S. FDA –
– If Authorized, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Twice Yearly –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). The proposed indication is for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations.
The application will be reviewed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) under the centralized licensing procedure for all 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein.
“Lenacapavir is a breakthrough innovation that has the potential to be transformative for people with multi-drug resistant HIV, who have very limited treatment options,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “The MAA validation is a step forward in our commitment to a patient-centered approach to helping all individuals living with HIV achieve and sustain viral load suppression, irrespective of their prior treatment history.”
The MAA is supported by data from the ongoing CAPELLA study, which achieved its primary endpoint by demonstrating that a significantly higher proportion of participants randomly allocated to receive oral lenacapavir in combination with an optimized background regimen (n=24) achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those randomly allocated to receive placebo (n=12) during the 14-day functional monotherapy period (88% vs. 17%, p
