Business Honor: FDA Approves Gilead’s Bixlenvo HIV Pill

US FDA approves Gilead’s once-daily HIV treatment Bixlenvo

Bio Tech

Gilead’s Bixlenvo combines bictegravir and lenacapavir in a once-daily pill for adults with already suppressed HIV.

The U.S. Food and Drug Administration (FDA) has approved Gilead’s once-daily oral combination tablet, Bixlenvo, for the treatment of adults living with HIV whose infection is already suppressed to very low levels, the company said Thursday.

The combination therapy Bixlenvo is made up of two Gilead HIV medicines – bictegravir and lenacapavir. Bictegravir is one of the active ingredients in Biktarvy, a highly popular treatment drug for HIV with an impressive barrier to resistance. Lenacapavir is the name of the HIV treatment drug marketed as Sunlenca and the HIV prevention drug marketed as Yeztugo.

At first, patients will get Sunlenca for two days, followed by Bixlenvo once a day. The company anticipates that the new therapy would be available to patients in the coming days after approval.

This approval decision has been based on data from two late-stage trials. Within 48 weeks, Bixlenvo was found to be equally efficacious as the complex multiple pill regimen or Biktarvy in achieving viral suppression.

The therapy can be simpler than the current therapies used by the patient for taking multiple pills due to the presence of drug-resistant HIV, commented Monika Shah, infectious disease expert from Memorial Sloan Kettering Cancer Center.

As per Gilead, Bixlenvo forms part of their strategy for growing their HIV portfolio through lenacapavir. The company expects that 5% of those living with HIV in the US will be taking treatment programs that involve more than one tablet daily.

Bixlenvo enters the competitive market for HIV treatment that has Merck’s Idvynso, which is a once-daily dual therapy approved in April for some adults with repressed HIV-1 infection.

The wholesale acquisition price of Bixlenvo for 30 days’ treatment is $4,595, as stated by a Gilead spokesperson. Business Honor believes Bixlenvo’s approval could simplify HIV treatment, offering eligible patients a convenient once-daily option while strengthening Gilead’s position.