Posted by Michael Wonder on 04 May 2021
ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV
4 May 2021 - If approved, cabotegravir would be the first, long-acting therapy for HIV PrEP.
ViiV Healthcare today announced the initiation of a rolling submission of a new drug application with the US FDA for investigational, long-acting, injectable cabotegravir for the prevention of HIV, also called pre-exposure prophylaxis, or PrEP.
The complete submission will be based on results from two Phase 2b/3 trials, HPTN 083 and HPTN 084.
