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December 23, 2021 - Long-Acting, Injectable PrEP Option Approved by FDA

For the first time, a non-daily option for reducing the risk of sexually-acquired HIV will be available in the US, according to an announcement from the US Food and Drug Administration (FDA). A long-acting, injectable form of Pre-Exposure Prophylaxis, or PrEP, was approved by the FDA on December 20, 2021. Critically, the FDA approved the new prescription treatment for use by at-risk adolescents who weigh at least 35 kilograms (77 pounds), along with at-risk adults, the announcement said.

Previously, PrEP was approved and available in oral form. The newly approved long-acting, injectable PrEP is known as Apretude (or extended-release cabotegravir). The FDA’s approval of Apretude presents a new tool for people who are at-risk for acquiring HIV from sex. Read the FDA’s announcement for more about treatment frequency recommendations and other important information.

The FDA’s announcement represents a milestone in the effort to end the HIV epidemic. The use of PrEP is part of the Prevention strategy, one of the four strategies that make up the US initiative of "Ending the HIV Epidemic" (EHE). The EHE strategy is to reduce HIV infections in the US by 90% by the year 2030. Read more about the EHE here.

Read about the clinical trials from the HIV Prevention Trials Network (HPTN) that helped inform the FDA’s decision.

The National Institutes of Health (NIH) also issued a statement - read it here.