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Sarilumab Meets Primary Endpoint in Phase 3 Comparative Study With Adalimumab
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Sanofi and Regeneron Pharmaceuticals Inc. announced sarilumab met its primary endpoint in a phase 3, 24-week comparison trial against adalimumab in patients with rheumatoid arthritis, according to a press release.
The trial included 369 patients with active, moderate to severe rheumatoid arthritis (RA) who did not respond adequately to or were intolerant of methotrexate. Patients were randomly assigned to received either subcutaneous sarilumab monotherapy at 200 mg every 2 weeks or adalimumab monotherapy at 40 mg every 2 weeks, according to a press release from Regeneron Pharmaceuticals.
“In this study, sarilumab monotherapy provided stronger efficacy than adalimumab monotherapy. Adalimumab is one of the most commonly used biologic medicines in RA,” Janet van Adelsberg, MD, senior director of Clinical Sciences, Immunology and Inflammation at Regeneron, said in a press release. “This is the first time an [interleukin] IL-6 receptor blocker delivered subcutaneously has demonstrated superiority over adalimumab monotherapy in RA.”
“Despite the availability of a wide range of treatment options, we believe that new therapies are needed to further address unmet needs of RA patients,” Simon Cooper, MBBS, vice president and global project head for Immunology and Inflammation at Sanofi, said in the release. “These data suggest that sarilumab, if approved, may be an option for patients unable to tolerate or take methotrexate, and we look forward to sharing further details at an upcoming medical congress.”
In January, the companies submitted a biologics license application to the FDA with a target action date of Oct. 30, 2016.
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