ViiV, J&J's Cabenuva gains FDA approval as long-acting regimen for HIV

ViiV Healthcare and Johnson & Johnson's Janssen Pharmaceutical unit announced that the FDA approved Cabenuva (cabotegravir/rilpivirine) as the first and only complete long-acting regimen in the US for the treatment of HIV-1 infection in adults. The co-pack of two injectable medicines includes ViiV's integrase strand transfer inhibitor Vocabria (cabotegravir) and Janssen's non-nucleoside reverse transcriptase inhibitor rilpivirine.

Cabenuva is indicated as an option to replace the current antiretroviral regimen in those who are virologically suppressed on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either Vocabria or rilpivirine. The FDA also approved Vocabria as a tablet formulation, and said it should be taken together with oral rilpivirine, which is sold as Edurant, for one month prior to starting Cabenuva in order to assess the tolerability of each before switching to the extended-release injectable regimen.

Once-monthly dosing

"Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition," remarked John Farley, director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research. Farley added that the approval of Cabenuva "will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen."

The decision is based on data from the Phase III ATLAS and FLAIR trials, with results showing that Cabenuva was as effective in maintaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly in the buttocks once a month throughout the 48-week study period. ViiV and Janssen said findings also indicated that Cabenuva was preferred by nine out of 10 patients over their previous daily oral therapy in these studies.

Approval follows CRL

The FDA issued a complete response letter (CRL) for Cabenuva in 2019, with the agency flagging problems with chemistry, manufacturing and controls (CMC). However, the companies said at the time that there had been "no reported safety issues related to CMC and there is no change to the safety profile of the products used in clinical trials to date."

ViiV stated it will begin shipping Cabenuva to wholesalers and specialty distributors in the US in February, with a price of $5940 for the initial injection, falling to $3960 per month afterward. The company said the cost is "within the range" of that for current once-daily oral combinations.

Meanwhile, the long-acting injectable treatment was approved in Canada last year, as well as in Europe, where regulators cleared both a once-monthly and once-every-two-month version of the regimen. Regulatory reviews continue in Australia and Switzerland.

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