The European Commission (EC) has approved Kevzara (sarilumab) for adult patients with moderate to severe active rheumatoid arthritis (RA). The drug can be used in combination with methotrexate (MTX) or as a monotherapy.
The approval was based on results from seven Phase III trials in the global SARIL-RA clinical development programme of more than 3,300 adults with moderate to severe active RA who have had an inadequate response or intolerance to previous. Kevzara in combination with conventional disease modifying anti-rheumatic drugs (DMARDs), including MTX showed statistically significant, clinically meaningful improvements in two pivotal phase III studies.
Twenty percent improvement in RA signs and symptoms measured with the American College of Rheumatology score (ACR20) at 24 weeks were 61 percent in the sarilumab 200mg plus MTX group; 56 percent in the sarilumab 150mg plus MTX group; and 34 percent in the placebo plus MTX group.
Kevzara (sarilumab) is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and inhibits pro-inflammatory IL-6R mediated signalling.
RA is a chronic inflammatory autoimmune disease that affects about 2.9 million people in Europe. The disease is difficult to treat with many clinicians challenged with finding treatments that work for their patients.
Kevzara therefore represents a new treatment alterative for European patients.