FDA Grants Priority Review to ViiV’s Long-Acting Cabotegravir for HIV PrEP

This alert is of competitive interest to Gilead's marketed Descovy (emtricitabine/tenofovir alafenamide) and Truvada (emtricitabine/tenofovir disoproxil fumarate) for HIV PrEP and investigational long-acting investigational lenacapavir and bictegravir for HIV prophylaxis and treatment of HIV.

ViiV Healthcare announced that the FDA has accepted and granted Priority Review for a NDA for investigational, injectable cabotegravir long-acting for pre-exposure prophylaxis, or PrEP. The Priority Review designation of cabotegravir long-acting for PrEP builds upon its prior identification as a Breakthrough Therapy by the FDA.
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 FDA has set a target approval date of 24 January 2022.

The NDA was based on the results from two phase IIb/III studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in men who have sex with men, transgender women, and cisgender women. The blinded, randomized portions of both studies were stopped early by independent Data Safety Monitoring Boards after cabotegravir was shown to be superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets in preventing the acquisition of HIV.

link to press release