FDA Approves First Injectable For HIV Pre-Exposure Prevention - GSK, Pfizer Backed Treatment

The FDA has approved ViiV Healthcare's Apretude (cabotegravir extended-release injectable suspension) for use in adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. 

• ViiV Healthcare is majority-owned by GlaxoSmithKline plc (NYSE: GSK), Pfizer Inc (NYSE: PFE), and Shionogi Limited.
• Apretude is given first as two initiation injections administered one month apart and then every two months after that. 
• Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug. 
• Cabenuva is the first and only complete long-acting HIV treatment regimen and was first approved by the FDA in January 2021 as a once-monthly treatment for HIV-1 in virologically suppressed adults.
• Related: Long-Acting HIV Treatment Backed By GSK, Pfizer Scores FDA Approval As Preventative Option.
• The safety and efficacy of Apretude were evaluated in two trials that compared Apretude to Truvada, a once-daily oral medication for HIV PrEP. 
• Price Action: GSK stock is up 0.48% at $45.04, PFE shares are down 0.06% at $52.66 during the market session on the last check Tuesday.