Treats human immunodeficiency virus type 1 (HIV-1) infection. NDA 221104, held by Gilead Sciences Inc. Bictegravir Sodium; Lenacapavir Sodium.
As of Nov 14, 2026, NDA 221104 (Bixlenvo), held by Gilead Sciences Inc, was first approved by FDA on Aug 27, 2026, with 0 approved supplements and 0 published complete response letters.
BIXLENVO is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2026 | Original applicationNew combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| BixlenvoEQ 75MG BASE;EQ 50MG BASE · tablet;oral | Bictegravir Sodium; Lenacapavir Sodium | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
