The US Food and Drug Administration has agreed to review Regeneron and Sanofi’s biologic sarilumab as a treatment of rheumatoid arthritis.
Sarilumab is an investigational, fully human monoclonal antibody directed against the IL-6 receptor that has been developed for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA).
The drug’s application contains data from around 2,500 patients who had an inadequate response to previous treatment regimens, including seven studies from the global SARIL-RA Phase III program.
Recently released data from the SARIL-RA-TARGET study showed “clinically relevant and statistically significant improvements” versus the placebo arm on co-primary endpoints of improving symptoms of the disease and physical function.
Improvement in signs and symptoms of RA at 24 weeks, as measured by the American College of Rheumatology score of 20 percent improvement (ACR20), were: 61 percent in the sarilumab 200mg group; 56 percent in the sarilumab 150mg group; and 34 percent in the placebo group, all in combination with disease-modifying anti-rheumatic drugs.
The companies are expecting a decision by the FDA by October 30 this year.
