LENACAPAVIR: EMA filing of the MAA in EU expected at the beginning of August 2021

Lenacapavir is an investigational, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV infection. Lenacapavir's multi-stage mechanism of action profile is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting regimens for people living with or at risk for HIV. While most antivirals act on just one stage of viral replication, lenacapavir is developed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes.

Gilead will submit the Marketing Authorization Application in EU at the beginning of August 2021 for EMA assessment