The FDA announced Friday that the agency approved Johnson & Johnson's once-daily compound Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in treatment-naïve adult patients.
The regulator noted that Edurant was approved based on two Phase III trials involving more than 1300 patients with HIV. Results showed that the non-nucleoside reverse transcriptase inhibitor was as effective in lowering viral load as Bristol-Myers Squibb's Sustiva (efavirenz). Furthermore, fewer patients ceased taking Johnson & Johnson's product due to side effects as compared to patients receiving Sustiva.
However, study results announced last July showed that 9 percent of patients developed resistance to Edurant compared with 5 percent on Sustiva. Decision Resources analyst Courtney Stanton said “In the grand scheme of things, 9 percent is still pretty low, but Atripla is such a powerhouse in this space, that it’s going to be hard to displace." Gilead’s Atripla generated $2.93 billion in revenue last year.
Nonetheless, today's approval "clears a hurdle for a planned combination pill with [Gilead's] Truvada that may generate more than $1 billion in annual sales," according to the analyst.
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