FDA rejects ViiV, Johnson & Johnson's once-monthly HIV regimen combining cabotegravir, Edurant

ViiV Healthcare announced that it has received a complete response letter from the FDA regarding a filing for the long-acting regimen combining its investigational drug cabotegravir plus Johnson & Johnson's Edurant (rilpivirine) to treat HIV-1 infection in virologically suppressed adults. "We believe the once-monthly, long-acting regimen represents an important therapeutic advance for those living with HIV," said Brian Woodfall, global head of development for infectious diseases at Johnson & Johnson's Janssen Biopharma unit, adding "we will continue to collaborate with...the FDA to fully understand the requirements needed to support US approval." 

According to the companies, the FDA flagged problems with chemistry, manufacturing and controls (CMC), although "there have 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." 

The submission was supported by data from the Phase III ATLAS and FLAIR trials, which involved more than 1100 adults with virologically suppressed HIV. Results showed that the once-monthly injectable combination of cabotegravir, an integrase strand transfer inhibitor, and Edurant, a non-nucleoside reverse transcriptase inhibitor, met the primary endpoint of non-inferiority in maintaining viral suppression in adults with HIV-1, versus a daily oral three-drug regimen, through 48 weeks. 

Besides the US, the two-drug regimen, which is not approved anywhere in the world, is also under review in Canada and Europe. Meanwhile, the companies recently reported that the combination also met the main goal of the Phase III ATLAS-2M study, with the regimen, administered every eight weeks, demonstrating similar efficacy compared to every four weeks over a 48-week treatment period. 

ViiV and Johnson & Johnson are developing the combination of cabotegravir and Edurant under a collaboration forged in 2016. GlaxoSmithKline, which holds a majority stake in ViiV alongside minority investors Pfizer and Shionogi, previously identified cabotegravir as one of as many as 20 investigational assets that could be submitted for regulatory approval by 2020. 

ViiV's two-drug, single-tablet regimen Dovato (dolutegravir/lamivudine) was approved earlier this year in regulators in both the US and Europe in certain patients with HIV-1 infection. 

For related analysis, see ViewPoints: ViiV’s long-acting HIV alternative just got longer.

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