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GlaxoSmithKline’s HIV drug Cabenuva scores FDA nod for 2-month dosing

Last January, when GlaxoSmithKline’s ViiV Healthcare won a long-awaited approval for its long-acting HIV treatment Cabenuva, it was hailed as a game-changer as it removed the burden of taking a daily pill.

Just over a year later, another nod from the FDA has made Cabenuva an even more convenient option, allowing a boosted formulation of the injected treatment to be taken every two months, instead of monthly.

The drug is for virologically suppressed adults on a stable regimen with no history of treatment failure and no known or suspected resistance to the two agents that make up Cabenuva—ViiV’s cabotegravir and Johnson & Johnson’s Edurant.

“We know some people living with HIV struggle with taking daily oral pills and Cabenuva may allow them to maintain viral suppression while significantly reducing dosing to as few as six times a year,” Lynn Baxter, ViiV’s chief in North America, said in a release.

One such U.S. patient, identified by ViiV, who applauded the FDA approval is Jayson (last name omitted), a senior director of security who has been living with HIV for more than 20 years.

“In my experience, with more time between treatments, taking Cabenuva every other month gives me the freedom to live my life with less worry about my HIV,” he said. “(With this), I am confident that I’m staying undetectable.”

Jayson, a senior director of global security who has been living with HIV for more than 20 years.

Cabenuva appeared destined for approval in the United States in late 2019 before manufacturing problems surfaced. Canada was the first to approve the drug in March 2020, followed in December of the same year by Europe. Both Canada and Europe have signed off on the two-month dosage regimen.

The long-acting HIV drug nabbed its original approvals after a phase 3 study of 1,045 participants showed that its once-a-month regimen performed comparable to daily antiretroviral pills. A subsequent trial showed that a two-month formulation worked as well as shots once a month.

Of 327 patients with no previous experience with Cabenuva, 92% preferred every-two-month injections to daily pills. Just 1% preferred the daily oral doses, which were required as a lead-in to injections.

Cabenuva marks GSK’s latest effort at broadening its HIV portfolio. Besides Cabenuva, it has two-drug regimens Dovato and Juluca trying to steal share from traditional triplets and establish a new treatment standard.

Right now, Gilead Sciences’ Biktarvy is the best-selling HIV treatment with $7.26 billion of sales in 2020. By contrast, GSK’s entire HIV portfolio brought in $4.88 billion in 2020.

ViiV also sells the cabotegravir component in Cabenuva as a challenger to Gilead’s monopoly in the HIV prevention field, or PrEP. The ViiV drug, given every two months, won FDA approval in December as a long-acting prevention option. Its brand name in that use is Apretude.