FDA Grants Priority Review for Cabotegravir to Prevent HIV

The FDA has accepted and granted priority review for a new drug application (NDA) for cabotegravir from ViiV Healthcare, an injectable for pre-exposure prophylaxis (PrEP), ViiV Healthcare’s parent company GlaxoSmithKline said in a statement.

“The FDA’s priority review designation of cabotegravir long-acting for PrEP underscores the importance of this medicine, supported by the results of the [HIV Prevention Trial Network] studies, which demonstrated cabotegravir’s superior efficacy over daily oral [tenofovir disoproxil fumarate with emtricitabine(TDF/FDC)] tablets,” Kimberly Smith, MD, MPH, head of research and development at ViiV Healthcare, said in the statement.

If approved, this drug would be the first, long-acting therapy to prevent HIV for individuals at risk of infection, who have a negative HIV-1 test. The NDA was based on the results from 2 phase 2b and 3 studies to evaluate the efficacy and safety of cabotegravir.

The studies were stopped early by independent Data Safety Monitoring Boards after cabotegravir was shown to be more effective than daily TDF/FDC fumarate tablets.

“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,” Smith said.

The priority review designation of cabotegravir builds upon its prior identification as a breakthrough therapy.

The FDA’s targeted approval date is January 24, 2022.

Reference

FDA grants priority review to ViiV Healthcare’s new drug application for cabotegravir long-acting for prevention of HIV. GSK. News release. September 28, 2021. Accessed September 30, 2021. https://www.gsk.com/en-gb/media/press-releases/fda-grants-priority-review-to-viiv-healthcare-s-new-drug-application-for-cabotegravir-long-acting-for-prevention-of-hiv/