The FDA issued approval for extended-release injectable cabotegravir (Apretude, CAB-LA) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.
The priority review approval was based on phase 2b-3 clinical trial data submitted to the agency this past August, after one of the studies was stopped early because of encouraging efficacy results of the first pre-planned interim endpoint analysis.
Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.
Source: FDA.gov