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Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options
If Approved, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Every 6 Months – Gilead Sciences, Inc. announced today that the company completed submission of a New Drug Application to the U.S. Food and Drug Administration seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily …
If Approved, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Every 6 Months –
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March 09, 2021
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– Late-Breaking Preclinical Data Support Further Study of Lenacapavir as a Long-Acting Agent for HIV Prevention – FOSTER CITY, Calif. (BUSINESS WIRE)
Gilead Sciences, Inc. (Nasdaq: GILD) today presented additional results from the Phase 2/3 CAPELLA trial evaluating the company’s investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The data build on the positive primary endpoint results announced previously. The new interim efficacy results demonstrate that lenacapavir administered subcutaneously every six months maintained high rates of virologic suppression through 26 weeks in a difficult-to-treat patient population with limited therapy options and high unmet medical need. In this analysis of the ongoing maintenance period of CAPELLA, which evaluated lenacapavir in combination with an optimized background regimen, 73% (n 19/26) of participants who reach
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