BIKTARVY

批准信原文要点

This Prior Approval supplemental new drug application supports use of Biktarvy in people living with HIV-1 with an antiretroviral treatment history and who are not virologically suppressed, and who have no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir.

批准信原文要点

This “Changes Being Effected in 30 days” supplemental new drug application provides for addition of new presentation for BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, 30/120/15 mg, low dose tablets (LDT) with a non-functional score line.

批准信原文要点

This Prior Approval supplemental new drug application provides for: 1. Updates to DOSAGE AND ADMINISTRATION section with new sub-section 2.4, Recommended Dosage in Pregnant Individuals.

批准信原文要点

This Prior Approval supplemental new drug application provides for: 1. New data from trial GS-US-380-4030 to support use of Biktarvy for the treatment of HIV-1 infection in virologically suppressed adults and pediatric patients on a stable HIV-1 treatment regimen with no known resistance to bictegravir or tenofovir 2. Update to ADVERSE REACTIONS, Postmarketing Experience with a new adverse reaction, weight increase 3. Update to USE IN SPECIFIC POPULATIONS and PATIENT COUNSELING INFORMATION lactation sections, and Patient Package Insert’s “What should I tell my healthcare provider before taking BIKTARVY? section with updated breastfeeding recommendations

批准信原文要点

This Prior Approval sNDA responds to a February 2, 2023, Prior Approval Supplement Request from the FDA to update the Biktarvy container labeling to provide for better visual differentiation between the Biktarvy (B/F/TAF) adult strength tablets (50 mg/200 mg/25 mg) from the Biktarvy (B/F/TAF) low-strength tablets (30 mg/120 mg/15 mg) tablets.

批准信原文要点

This Prior Approval supplemental new drug application provides to update the Prescribing Information with additional Week 144 efficacy and safety data for antiretroviral therapy-naïve adult patients with HIV-1 infection.

批准信原文要点

This Prior Approval supplemental new drug application provides for for the following changes to the Prescribing Information and Patient Information:  To expand the patient population for Biktarvy to include HIV-1 infected pediatric patients weighing at least 14 kg. This change is supported by safety and efficacy data in HIV-1 infected, virologically suppressed pediatric subjects, from Cohort 3 of the Clinical Trial GS-US-380-1474.  To add a new Biktarvy Low-Dose Tablet (B/F/TAF 30/120/15 mg).

批准信原文要点

This prior approval supplemental NDA provides for the following labeling updates: USE IN SPECIFIC POPULATIONS, PREGNANCY section is updated with information from the latest Antiretroviral Pregnancy Registry Interim Report

批准信原文要点

This Prior Approval supplemental new drug application proposes to update the United States Prescribing Information (USPI) for BIKTARVY with information regarding the risk of renal toxicity associated with the use of tenofovir alafenamide (TAF) in the WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, Clinical Trials Experience and Postmarketing Experience subsections, and PATIENT COUNSELING INFORMATION.

批准信原文要点

This Prior Approval supplemental new drug application provides updates to the USE IN SPECIFIC POPULATIONS and CLINICAL STUDIES sections of the United States Prescribing Information (USPI) for Biktarvy, with additional safety and efficacy information pertaining to use of Biktarvy in virologically suppressed, HIV-1 infected subjects aged 65 years and over.

批准信原文要点

To update the ADVERSE REACTIONS, Postmarketing Experience subsection with information regarding the risk of Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) associated with the use of Biktarvy.

批准信原文要点

These data were submitted to support the use of Biktarvy for the treatment of HIV-1 infection in virologically-suppressed, adult patients, with estimated creatinine clearance below 15 mL per minute who are receiving chronic hemodialysis.

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to the USE IN SPECIFIC POPULATIONS, Pregnancy subsection of the prescribing information for BIKTARVY® to include currently available information regarding the increased risk of neural tube defects associated with the use of dolutegravir, another integrase inhibitor.

批准信原文要点

To expand the patient population for BIKTARVY® to include HIV-1 infected pediatric patients weighing at least 25 kg. This change is supported by safety and efficacy data in HIV-1 infected, virologically suppressed adolescents and children from Clinical Trial GS-US-380-1474.