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ViiV Healthcare announces FDA approval of Apretude
ViiV Healthcare announces FDA approval of Apretude.
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[{"type":"text","content":"\n \n \n \n RNS Number : 2725W\n GlaxoSmithKline PLC\n 20 December 2021\n \n \n \n \n Issued: 20 December 2021, London UK - LSE announcement\n \n \n \n \n \n \n ViiV Healthcare announces US FDA approval of \n \n \n Apretude\n \n \n \n \n \n (cabotegravir extended-release injectable suspension), the first and only long-acting injectable option for HIV prevention\n \n \n \n · \n \n Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition\n \n \n \n · \n \n Approved in the US for use in adults and adolescents weighing at least 35 kg who are at risk of sexually acquiring HIV, including men who have sex with men as well as women and transgender women who have sex with men\n \n \n \n \n \n \n \n London, 20 December 2021\n \n - ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) as shareholders, today announced that the US Food and Drug Administration (FDA) approved Apretude, the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV-1. The long-acting injectable was approved for use in adults and adolescents weighing at least 35 kg who are at risk of sexually acquiring HIV and who have a negative HIV-1 test prior to initiation. The medicine was studied in men who have sex with men, as well as women and transgender women who have sex with men, who were at increased risk of sexually acquiring HIV.\n \n Cabotegravir long-acting for PrEP is provided as an injection given as few as six times per year and is initiated with a single 600 mg (3-ml) injection given one month apart for two consecutive months. After the second initiation injection, the recommended continuation injection dose is a single 600 mg (3-ml) injection given every two months. Vocabria (cabotegravir oral tablets) may be administered for approximately one month before initiating the first injection to assess the tolerability of the medicine.\n \n \n Deborah Waterhouse, CEO, ViiV Healthcare, said: \"People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the US, may want options beyond daily oral pills....