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ViiV Healthcare : FDA Approves Apretude, Long-acting Injectable Option For HIV Prevention

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK,GSK.L), with Pfizer Inc. (PFE) and Shionogi Limited as shareholders, said that the US Food and Drug Administration approved Apretude, long-acting injectable pre-exposure prophylaxis option to reduce the risk of sexually acquired HIV-1.

The long-acting injectable was approved for use in adults and adolescents weighing at least 35 kg who are at risk of sexually acquiring HIV and who have a negative HIV-1 test prior to initiation.

Apretude is administered as a single 600 mg (3-ml) intramuscular (IM) injection of cabotegravir in the buttocks by a health care provider every two months after two initiation injections administered one month apart and an optional oral lead-in to assess tolerability.

ViiV Healthcare noted that it will begin shipping Apretude to wholesalers and specialty distributors in the US in early 2022. ViiV Healthcare has initiated submissions to other regulatory authorities. Apretude has not been approved or licensed anywhere outside of the US for use in HIV prevention.

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