FDA Approves Gilead Sciences' Bixlenvo for Certain Adults With HIV
By Stephen Nakrosis
Gilead Sciences said the Food and Drug Administration has approved Bixlenvo for certain adult patients with HIV who are virologically suppressed.
Bixlenvo, or bictegravir and lenacapavir in combination, is the smallest single once-daily single tablet regimen to treat these patients, the company said. Bixlenvo is also the first and only STR option for virologically suppressed patients with HIV who are on complex regimens and unable to take currently available STRs, the company added.
In a pair of trials, Bixlenvo demonstrated comparable efficacy in maintaining virologic suppression at week 48 and was generally well tolerated, and no significant or new safety concerns were identified, Gilead said.
Bictegravir and lenacapavir in combination aren't approved by any regulatory authority outside of the U.S., Gilead added.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
August 27, 2026 18:56 ET (22:56 GMT)
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