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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 Limited Therapy Options

EMA MAA Validation Follows Submission of NDA for Lenacapavir to the U.S. FDA – – If Authorized, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Twice Yearly – Gilead Sciences, Inc. today announced that the company’s Marketing Authorization Application for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now . ....

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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

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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