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

For the first time, an option for the prevention of HIV from sex will be available in the US other than a daily medication, 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 treatment for prescription use by at-risk adolescents who weigh at least 77 pounds, along with at-risk adults, the announcement said.

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

The FDA’s announcement represents a major milestone towards ending the HIV epidemic. The use of PrEP is a piece of one of the four pillars of the “Ending the HIV Epidemic in the US,” or EHE, plan. The plan’s goal 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.