Therapy Areas: AIDS & HIV
European Medicines Agency Validates Gilead's Marketing Authorization Application for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People with Ltd. Therapy Options
20 August 2021 - - US-based biopharmaceutical company Gilead Sciences, Inc's (NASDAQ: GILD) Marketing Authorization Application for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency, the company said.

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 under the centralized licensing procedure for all 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein.

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 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 during the 14-day functional monotherapy period (88% vs. 17%, p


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