ViiV Healthcare has announced the FDA approval of Apretude (cabotegravir), which it bills as the “first and only” long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV-1.
The drug can be administered as few as six times per year.
The FDA approval covers adults and adults who weigh at least 35 kg and have a negative HIV-1 test before beginning therapy.
ViiV Healthcare is a joint venture between GlaxoSmithKline (LON:GSK), Pfizer (NYSE:PFE) and Shionogi.
“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,” said Dr. Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option,” Birnkrant said in a statement.
ViiV Healthcare also manufactures cabotegravir tablets known as Vocabria.
It plans to begin shipping Apretude in early 2022.
Filed Under: Infectious Disease
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