EMA validates Gilead's lenacapavir MAA for HIV-1 patients with limited options

20 August 2021
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Gilead Sciences (Nasdaq: GILD) has announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, a long-acting HIV-1 capsid inhibitor, has been fully validated and is now being evaluated by the European Medicines Agency (EMA).

The proposed indication is for the treatment of HIV-1 infection, in combination with other antiretrovirals, in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations.

"Has the potential to be transformative for people with multi-drug resistant HIV"This 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.

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