FDA Approves Biktarvy Label Update With Data For Pregnant Adults With HIV; Perinatal Guidelines Recognize Biktarvy As Alternative Regimen For Use During Pregnancy And For Those Trying To Conceive
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The FDA has approved an updated label for Gilead Sciences' Biktarvy, including additional data supporting its safety and efficacy for treating pregnant adults with HIV-1. This makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen with FDA approval for this group. The update is based on Study 5310, which showed maintained viral suppression and no new safety concerns during and post-pregnancy. The DHHS perinatal guidelines now recommend Biktarvy as an alternative regimen for pregnancy and conception.
April 26, 2024 | 12:05 pm
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Gilead Sciences' Biktarvy receives FDA label update for use in pregnant adults with HIV-1, based on Study 5310 data, reinforcing its safety and efficacy. This positions Biktarvy as a preferred treatment option, potentially enhancing Gilead's market share in HIV treatment.
The FDA approval of the label update for Biktarvy specifically for pregnant adults with HIV-1 highlights a significant advancement in treatment options for a vulnerable group. This approval not only strengthens Biktarvy's position in the market but also showcases Gilead Sciences' commitment to addressing the comprehensive needs of people living with HIV. The positive data from Study 5310 and the endorsement by DHHS guidelines could lead to increased prescriptions of Biktarvy, potentially improving Gilead's market share and financial performance in the short term.
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