FDA Clears First Long-Acting HIV Prevention Injectable

The FDA has approved Viiv Healthcare’s Apretude (cabotegravir) as the first injectable extended-release product for HIV prevention in adults and adolescents.

The approval was supported by two phase 2/3 studies with more than 7,700 total participants, demonstrating that the long-acting drug was superior to daily emtricitabine/tenofovir disoproxil fumarate tablets in preventing HIV.

The injection, which is administered every two months, will help “high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option,” said Debra Birnkrant, director of the antivirals division in the FDA’s Center for Drug Evaluation and Research.

ViiV plans to launch Apretude in the U.S. in early 2022.