ViiV Healthcare has received the US Food and Drug Administration (FDA) approval for Apretude (cabotegravir extended-release injectable suspension) as an injectable pre-exposure prophylaxis (PrEP) option for HIV prevention.
The long-acting injectable is indicated for use in adults and adolescents who are at risk of sexually acquiring HIV and test negative for HIV-1 before initiation.
The regulatory approval was based on data obtained from two global, double-blind, randomised, active-controlled, multicentre Phase IIb/III studies, HPTN 083 and HPTN 084.
These trials have assessed Apretude’s efficacy and safety in HIV-negative men who are at increased risk of sexually acquiring HIV.
In the trials, Apretude showed superior results in preventing the HIV acquisition compared to daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) tablets.
ViiV Healthcare CEO Deborah Waterhouse said: “People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the US, may want options beyond daily oral pills.
“That’s why ViiV Healthcare is proud that Apretude was studied in one of the most diverse and comprehensive HIV prevention trial programs to date, which also included some of the largest numbers of transgender women and Black men who have sex with men ever enrolled in an HIV prevention trial.
“With Apretude, people can reduce the risk of acquiring HIV with as few as six injections a year. Today’s approval is the latest example of ViiV Healthcare’s commitment to developing long-acting medicines that offer consumers a different choice.”
Apretude is given as a single 600 mg (3-ml) intramuscular (IM) injection as few as six times a year.
It will be initiated with two 600mg injections which will be given one month apart, and the recommended continuation doses will be given for every two months.
To assess the drug’s tolerability, Vocabria (cabotegravir oral tablets) may be given for about one month before initiating the treatment.
The company is slated to commence shipping Apretude to distributors in the US by early next year and also initiated submissions to other regulatory authorities for approval.