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Apretude for PrEP receives EMA approval
Apretude for PrEP receives EMA approval.
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 19 September 2023, London UK\n \nEuropean Commission authorises ViiV Healthcare's Apretude (cabotegravir long-acting and tablets) for HIV prevention\n \n· Given as few as six times per year, cabotegravir has demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition in clinical trials.[1],[2],[3],[4]\n· With approximately 100,000 people newly diagnosed with HIV each year in Europe,[5] expanding HIV prevention options is crucial in reducing HIV transmission.\n \n \n \n\nGSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced that the European Commission has authorised Apretude (cabotegravir long-acting (LA) injectable and tablets) for HIV prevention. Cabotegravir is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents (at least 12 years of age), weighing at least 35 kg.\n \nCabotegravir LA injectable and tablets for PrEP is the first and only HIV prevention option approved in the European Union (EU) that reduces the number of doses needed for effective HIV prevention from 365 daily pills to as few as six injections per year. Cabotegravir LA injectable and tablets for PrEP has demonstrated superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in reducing the risk of HIV acquisition in clinical trials, giving people in the EU more options for PrEP.1,2,3,4\n \nDeborah Waterhouse, CEO at ViiV Healthcare, said: \"This authorisation marks a pivotal milestone for people across the EU who could benefit from an innovative, long-acting HIV prevention option that may better suit their personal preferences. Long-acting PrEP, alongside other HIV prevention strategies, plays an important role in helping to address some of the challenges that people may have with oral PrEP options\".\n \nThis approval is supported by data from two international phase IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir LA for PrEP in HIV-negative men who have sex w...