ViiV Healthcare公司12月20日宣布,美国食品和药物管理局 (FDA) 批准了Apreude(cabotegravir,卡博特韦缓释注射悬浮液),这是首个PrEP的长效注射剂,用于有性行为感染 HIV 的风险,并且在开始前 HIV-1 检测呈阴性,体重至少 35 公斤的成人和青少年,用于降低性感染 HIV-1 的风险。 该药物在性行为中感染艾滋病毒风险增...
InJanuary 2021, the FDA approved CABENUVA to be administered every month to adults living with HIV-1. InFebruary 2022, the FDA approved an expanded label for CABENUVA to be administered every two months to ad...
US FDA approval is based on the results from two international phase IIb/III multicenter, randomised, double-blind, active-controlled trials, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in HIV-negative men who have sex with men, transgen...
The US FDA approval allows Cabenuva to be dosed monthly or every two months. Lynn Baxter, Head of North America at ViiV Healthcare, said:“ViiV Healthcare is pleased to continue our leadership in researching and developing long-acting innovative HIV treatment options that a...
CAB is a second-generation INSTI currently nearing USA FDA approval as a LA injectable18. While effective in PrEP and has generated attention by the scientific and patient community for both treatment and prevention of HIV/AIDS12,17,19 limitations in dosing volumes, intervals of administration, an...
Apretude,Vocabria Related treatment guides HIV Infection Pre-Exposure Prophylaxis Medical Disclaimer Drug Status AvailabilityPrescription onlyRx Pregnancy & LactationRisk data available CSA Schedule* Not a controlled drug N/A Approval History Drug history at FDA...
On January 21, 2021, theFDAgranted approval for the utilization ofcabotegravirtogether withrilpivirineto treat HIV-1 in individuals who have achieved virological suppression [123]. After its initial monthly dosing regimen, this combined product receivedFDAapproval on February 1, 2022, for a revised...
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(FDA) for the expanded use of Cabenuva (cabotegravir, rilpivirine). The sNDA seeks to expand Cabenuva’s label to include every 2-months dosing for the treatment of HIV-1 infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per milliliter [mL]) on a...
ViiV Healthcare receives FDA Breakthrough Therapy Designation for investigational, long-acting cabotegravir for HIV prevention. London: Viiv Healthcare; 2020. Google Scholar HPTN. HPTN-083 frequently asked questions. In: https://www.hptn.org/sites/default/files/inline-files/HPTN%20083%20DSMB%20...