PFE - ViiV Healthcare initiates rolling submission of cabotegravir in U.S. for HIV prevention

ViiV Healthcare has initiated a rolling submission of a new drug application ((NDA)) with the 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 IIb/III studies, HPTN 083 and HPTN 084. The Data Safety Monitoring Board stopped the blinded, randomised portion of both studies early after cabotegravir was shown to be superior to daily emtricitabine/tenofovir disoproxil fumarate tablets. ViiV Healthcare plans to start submission of regulatory files with global regulatory authorities by the end of this year and will initially focus submissions on countries where the HPTN 083 and HPTN 084 clinical trials were conducted.ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (GSK), Pfizer (PFE) and Shionogi (SGIOY).

For further details see:

ViiV Healthcare initiates rolling submission of cabotegravir in U.S. for HIV prevention