Posted by Michael Wonder on 17 Nov 2020
ViiV Healthcare receives FDA breakthrough therapy designation for investigational, long-acting cabotegravir for HIV prevention
17 November 2020 - ViiV Healthcare today announced that the US FDA 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 2b/3 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.
