European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV prevention

GSK

28 October 2022 - The marketing application is based on results from the HPTN 083 and 084 Phase 2b/3 studies in which the injectable medicine, given as few as six times per year, demonstrated superior efficacy to a daily oral PrEP option in reducing the risk of HIV acquisition.

ViiV Healthcare today announced that the EMA has validated the company’s marketing authorisation application seeking approval of cabotegravir long-acting injectable for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1.

Read GSK press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier