> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Gilead HIV Drug Gets Complete Response Letter
- URL: https://www.fdaweb.com/gilead-hiv-drug-gets-complete-response-letter/
- Published: 2022-03-01T12:00:00.000Z
- Updated: 2026-09-14T17:34:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151265

FDA has issued Gilead Sciences a complete response letter on its NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor for treating HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The agency cited chemistry, manufacturing and controls issues relating to the compatibility of lenacapavir with the proposed container vial as the reason to not approve the therapy. “FDA raised questions about vials made of borosilicate glass and their compatibility with lenacapavir solution, which has resulted in a clinical hold for injectable lenacapavir,” the company says.

“Gilead intends to provide FDA with a comprehensive plan and corresponding data to use a different vial type,” it says. “We look forward to discussing this further with FDA over the coming months so that we can make this investigational new therapy available to people living with multidrug-resistant HIV as soon as possible.”