Gilead Submits NDA for Lenacapavir to U.S. FDA

   By Stephen Nakrosis

Gilead Sciences Inc. on Monday said it completed its submission of a new drug application to the U.S. Food and Drug Administration for lenacapavir, an investigational treatment for certain patients with HIV-1.

The company said lenacapavir was a "long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection." The company also said lenacapavir was being studied as an every-six-month subcutaneous injection.

Merdad Parsey, the company's chief medical officer, said, "The filing moves us one step closer to providing an innovative treatment option that helps to address barriers to achieving viral suppression and meet the unmet needs of people living with multi-drug resistant HIV."

The company said its submission was supported by data from its Phase 2/3 CAPELLA trial, "which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen." Data from the trial will be presented at the 11th International AIDS Society Conference on HIV Science next month, Gilead said.

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

June 28, 2021 16:52 ET (20:52 GMT)

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