FDA grants Priority Review to Bictegravir/Lenacapavir (BIC-LEN) Once-Daily HIV treatment

U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) – an investigational, once-daily single-tablet combination regimen for the treatment of HIV in adults who are virologically suppressed. The FDA has granted priority review of the application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026.

The NDA submission is supported by positive Phase 3 data from the ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, which evaluated BIC/LEN in adults with HIV with virological suppression, including those who switched from complex multi-tablet regimens or from Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg).

In both trials, BIC/LEN demonstrated comparable efficacy in maintaining virological suppression at Week 48 and was generally well tolerated, with no significant or new safety concerns identified.

ARTISTRY-1 enrolled the oldest study population in a Phase 3 HIV treatment registrational trial to date. The Week 48 data presented at CROI 2026 showed the treatment switch to BIC/LEN from complex regimens was also associated with improvements in certain fasting lipid parameters and patient-reported treatment satisfaction. Detailed ARTISTRY-1 results were published in The Lancet on March 28, 2026.

ARTISTRY-2 showed that switching to BIC/LEN had no significant impact on weight.