Benzinga | Dec 21, 2021 06:42AM EST

Long-Acting HIV Treatment Backed By GSK, Pfizer Scores FDA Approval As Preventative Option

* The FDA has approved ViiV Healthcare's Apretude, the first and only long-acting injectable pre-exposure prophylaxis (PrEP) 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 have a negative HIV-1 test before initiation.

* Related Link: ViiV In-Licenses Third-Gen HIV Targeting Compound From Shionogi.

* The approval comes almost a month before the PDUFA date of January 24, 2022.

* ViiV Healthcare is a joint venture between GlaxoSmithKline plc (NYSE: GSK), Pfizer Inc (NYSE: PFE), and Shionogi.

* Cabotegravir long-acting for PrEP is provided as an injection given as few as six times per year and is initiated with a single 600 mg (3-ml) injection given one month apart for two consecutive months.

* After the second initiation injection, the recommended continuation injection dose is a single 600 mg (3-ml) injection given every two months.

* Vocabria (cabotegravir oral tablets) may be administered for approximately one month before initiating the first injection to assess the tolerability of the medicine.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: GSK stock is down 0.21% at $42.97, PFE shares are down 0.20% at $60.90 during the premarket session on the last check Tuesday.