New Drug Application submitted to FDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor for heavily treatment-experienced people with multi-drug resistant HIV-1 infection

If approved, lenacapavir would be first capsid inhibitor and only HIV-1 treatment administered every 6 months. Submission is supported by data from phase 2/3 CAPELLA trial of 6-monthly subcutaneously injections in combination with optimised background antiretroviral regimen

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Biospace Inc.