Type Whole antibody Target IL-6R ATC code L04AC14 (WHO) | Source Human Routes of
administration Subcutaneous injection Legal status Investigational | |
Sarilumab is a human monoclonal antibody against the interleukin-6 receptor.
Contents
Regeneron and Sanofi are currently co-developing the drug for the treatment of rheumatoid arthritis (RA), for which it is in phase III trials.
Development in ankylosing spondylitis has been suspended after the drug failed to show clinical benefit over methotrexate in a phase II trial.
Rheumatoid arthritis
On May 15, 2013, both companies announced that 2 new trials were starting (COMPARE and ASCERTAIN) and the first patients had already been enrolled.
In June 2015 a phase 3 trial (with methotrexate) for RA reported meeting its 3 coprimary endpoints.
In Nov 2015 the SARIL-RA-TARGET trial reported good results (meeting both its coprimary end points).
In Nov 2016 the MONARCH phase III trial comparing sarilimab to adalimumab (an anti-TNF) found sarilumab superior as a monotherapy for RA.
History
In October 2016 the US FDA refused approval (for RA) due to GMP violations.
Side effects of subcutaneous sarilumab
At 200 mg every 2 weeks, 13.6% of patients had neutropenia in one trial.