FDA Grants Priority Review for New Cabotegravir Long-Acting HIV Prevention and Treatment Drug

Cabotegravir has a target date of January 24, 2022 and would become the first long-acting HIV PrEP therapy approved.


ViiV Healthcare announced today the Food and Drug Administration (FDA) has granted Priority Review for a New Drug Application (NDA) for cabotegravir, for an HIV prevention indication.

The FDA set a target approval date of January 24, 2022, and if approved, cabotegravir will be the first long-acting therapy for HIV prevention.

Cabotegravir is an injectable form of pre-exposure prophylaxis (PrEP) intended for individuals at risk of sexually acquired HIVinfection. The Priority Review status comes after its prior FDA designation as a breakthrough therapy.

The NDA was granted upon reviewal of two phase 2b/3 double-blind studies, HPTN 083 and HPTN 084, that evaluated the safety and efficacy of cabotegravir long-acting. The participants of HPTN 083 included 4566 men who have sex with men and transgender women who have sex with men, and the participants in HPTN 084 included 3223 cisgender women who were at increased risk of HIV infection. HPTN 083 opened to enrollment in November 2016, and HPTN 084 opened to enrollment in November 2017.

The trials included an oral lead-in to ensure all test subjects could tolerate cabotegravir long before commencing intramuscular injections every eight weeks.

The most common side effects experienced by at least 1% of test subjects were injection site reaction, diarrhea, headache, sleep disorders, fatigue, dizziness, nausea, and abdominal pain. Additionally, some participants in HPTN 083 experienced pyrexia and flatulence, and some participants in HPTN 084 experienced vomiting, myalgia, and rash.

Both trials were halted early by Data Safety Monitoring Boards after initial results showed long-acting cabotegravir to be superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in preventing HIV acquisition.

Kimberly Smith, MD, MPH, head of Research & Development at ViiV Healthcare, emphasized the significance of cabotegravir long-acting receiving FDA Priority Review, which she touted as proof of the injection’s efficacy over previous PrEP drugs.

Smith added, “In the United States, fewer than 25% of those who could benefit from PrEP are currently taking it, which points to the need for additional HIV prevention options. We believe new options like investigational cabotegravir long-acting for PrEP will help play a significant role in our collective efforts to end the HIV epidemic.”