Gilead files with the US Food and Drug Administration for approval of its HIV drug lenacapavir

US – The American biopharmaceutical company, Gilead Sciences has filed its investigational long -acting HIV therapy, lencapavir with the US Food and Drug Administration (USFDA) for approval as therapy for patients with multi-drug resistant infection. In its submission, Gilead has included data from the Phase II/III CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously (under the skin) every six months in combination with an optimized antiretroviral background regimen. The FDA has already granted lenacapavir a breakthrough therapy designation for the treatment of HIV-1 infection in this…

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