SGIOF - FDA grants Priority Review to Viiv Healthcare's cabotegravir long-acting NDA in HIV

The FDA has accepted and granted Priority Review for ViiV Healthcare's New Drug Application (NDA) for investigational, injectable cabotegravir long-acting for pre-exposure prophylaxis, or PrEP. The FDA has set a target approval date of 24 January 2022. If approved, cabotegravir would be the first, long-acting therapy for the prevention of HIV for individuals at risk of sexually acquired HIV-1 infection, who have a negative HIV-1 test prior to initiation. The NDA was based on the results from two phase IIb/III studies, HPTN 083 and HPTN 084. The blinded, randomized portions of both studies were stopped after cabotegravir was shown to be superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets in preventing the acquisition of HIV. ViiV Healthcare will initiate submissions of cabotegravir long-acting for PrEP to other regulatory authorities by year end. ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY). Earlier, ViiV Healthcare's

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FDA grants Priority Review to Viiv Healthcare’s cabotegravir long-acting NDA in HIV