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U.S. Approves First HIV Prevention Injection, Set to Arrive Early 2022

The U.S. Food and Drug Administration has approved a new injectable treatment for HIV pre-exposure prevention.

The drug, Apretude, is approved for at-risk adults and adolescents who weigh at least 77 pounds to reduce the risk of sexually acquired HIV, the FDA announced Monday.

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in the announcement.

After the initial two injections, Apretude is administered one month apart, then every two months after that. The hope is that high-risk individuals, like men who have sex with men, will have better adherence to taking the PrEP injectable option every two months versus taking a pill every day.

Until now, two types of daily pills (Truvada and Descovy) were the only options for what’s called pre-exposure prophylaxis (PrEP), but adhering to these daily medications to prevent HIV can be difficult, the FDA noted.

The injection will be manufactured by Glaxo.

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