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U.S. FDA Grants Priority Review of New Drug Application for Gilead's Once-Daily HIV Treatment of Bictegravir Plus Lenacapavir
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April 29, 2026
- Novel Investigational Combination Pairs Bictegravir, Guideline-Recommended INSTI with High Barrier to Resistance, with Lenacapavir, a First-in-Class Capsid Inhibitor, Designed for Sustained Virologic Suppression for People Living with HIV -
- If Approved, Combination will be Smallest Single-Tablet Regimen (STR) for HIV Treatment and First STR Studied in Adults with Virological Suppression on Complex Multi-Tablet Regimens -
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the 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.
"This once-daily, single-tablet regimen brings together the high barrier to resistance of bictegravir, with lenacapavir, a first-in-class capsid inhibitor with a novel mechanism of action that has no cross-resistance with other antiretrovirals," said Dietmar Berger, M.D., Ph.D., Chief Medical Officer, Gilead Sciences. "If approved, BIC/LEN has the potential to be a single-tablet regimen designed to provide sustained virologic suppression with a high barrier to resistance for people living with HIV who are virologically suppressed, including those who are aging, with comorbidities, seeking to streamline a complex regimen, with prior ARV resistance, and those seeking novel treatment options."
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. ARTISTRY-2 showed that switching to BIC/LEN had no significant impact on weight. Detailed ARTISTRY-1 results were published in The Lancet on March 28, 2026.
"Gilead is committed to continuous scientific discovery to develop transformative medicines to help meet the needs and preferences of people living with HIV, especially as those needs evolve the longer individuals are on HIV treatment," said Jared Baeten, M.D., Ph.D., Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. "BIC/LEN, if approved, could help address those needs and complements our portfolio together with the trusted foundation of Biktarvy which is a standard of care for HIV treatment and will remain the cornerstone of our treatment portfolio."
Bictegravir plus lenacapavir in combination are investigational and not approved anywhere globally. The safety and efficacy of this combination have not been established. There is currently no cure for HIV or AIDS.
link to full press release
https://www.gilead.com/news/news-details/2026/u-s--fda-grants-priority-review-of-new-drug-application-for-gileads-once-daily-hiv-treatment-of-bictegravir-plus-lenacapavir
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