$PFE ViiV Healthcare, which is majority owned by GlaxoSmithKline (GSK), with Pfizer (PFE) and Shionogi Limited (SGIOY), announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation for long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis. The Breakthrough Therapy Designation was based on efficacy and safety results from HPTN 083, a phase IIb/III randomised, multicentre, double-blind, clinical trial that compared long-acting, injectable cabotegravir to daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg for HIV prevention among men who have sex with men and transgender women who have sex with men. Final analysis of HPTN 083 showed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets. This translated to an HIV incidence rate of 0.41% in the cabotegravir group and 1.22% in the FTC/TDF group in a study population of 4,566. The results of HPTN 083 were presented at the 23rd International AIDS Conference in July. The blinded phase of HPTN 084, a partner HIV prevention study in sub-Saharan African women, was stopped earlier this month based upon recommendation of the independent data safety monitoring board following demonstration that long-acting cabotegravir was superior to oral FTC/TDF tablets. ViiV Healthcare plans to use the data from both HPTN studies for future regulatory submissions. Read more at: https://thefly.com/n.php?id=3198238