Sanofi says its RA drug bested Humira in Phase III study
pharmafile | March 11, 2016 | News story | Medical Communications, Research and Development | Humira, Regeneron, Sanofi
Sanofi and its R&D arm Regeneron Pharmaceuticals say their monoclonal antibody sarilumab outperformed AbbVie’s Humira in treating the symptoms of active rheumatoid arthritis, as measured at week 24 by the National Rheumatoid Arthritis Society’s DAS28 scale.
Announcing topline data from the 369-patient SARIL-RA-MONARCH study, the companies also said that by week 24 of treatment, sarilumab met clinically-important secondary endpoints, including improvements in signs and symptoms of RA as measured by patients achieving a 20% improvement in the American College of Rheumatology (ACR) criteria. 72% of sarilumab patients achieved this 20% improvement figure, versus 58% for Humira (adalimumab).
The two treatments were found to have similar safety profiles, with serious adverse events reported in 5% of patients in the sarilumab arm, versus 7% in the Humira arm.
“In this study, sarilumab monotherapy provided stronger efficacy than adalimumab monotherapy. Adalimumab is one of the most commonly used biologic medicines in RA,” says Janet van Adelsberg, senior director, Clinical Sciences, Immunology and Inflammation, Regeneron. “This is the first time an 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,” adds Dr Simon Cooper, global project head, Immunology and Inflammation, Sanofi. “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.”
The FDA is currently reviewing Sanofi/Regeneron’s biologics license application for sarilumab, and is expected to make a decision by October 2016.
Joel Levy
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