The European Commission (EC) approved Regeneron’s and Sanofi’s interleukin-6 receptor (IL-6R)-targeting monoclonal antibody (mAb) Kevzara® (sarilumab) combined with methotrexate for treating moderately to severely active rheumatoid arthritis (RA) in adults who cannot tolerate or who do not respond adequately to one or more disease-modifying antirheumatic drugs (DMARDs). Regulatory approval in Europe also covers Kevzara monotherapy when methotrexate therapy isn’t tolerated or is inappropriate. FDA approved Kevzara last month, either as monotherapy or in combination with methotrexate or DMARDs, for treating adults who have had an inadequate response or who are intolerant to DMARDs.
Approval of Kevzara in Europe was based on data from the global SARIL-RA program, which included seven Phase III studies and more than 3000 patients. Results from the Phase III MONARCH trial indicated that Kevzara monotherapy was more effective than AbbVie’s Humira® (adalimumab) monotherapy in terms of reducing disease activity and improving physical function. The Phase III MOBILITY trial showed that Kevzara plus methotrexate reduced disease signs and symptoms, improved physical function, and inhibited progression of structural damage by up to 91% when compared with methotrexate plus placebo. In the Phase III TARGET trial, Kevzara plus a DMARD reduced disease signs and symptoms and improved physical function compared with DMARD plus placebo.
Commenting on EC approval of the antibody, Elias Zerhouni, M.D., president, global R&D at Sanofi, said, “Kevzara works differently from some of the other most commonly used biologics, and its approval is good news for the many patients where a high unmet need remains.”
“We are pleased to bring Kevzara to European patients who may not be responding to the most commonly used biologics, such as tumor necrosis factor inhibitors, or who may be seeking an effective monotherapy to reach their treatment goals,” added George D. Yancopoulos, M.D., Ph.D., founding scientist, president, and CSO at Regeneron.
Sanofi and Regeneron teamed up in 2007 to identify targets and develop antibody treatments for multiple therapeutic indications. Earlier this month, the firms presented positive data from the Phase IIIb/IV ODYSSEY-DM INSULIN and ODYSSEY-DM DYSLIPIDEMIA studies evaluating their globally marketed cholesterol-lowering PCSK9 antibody Praluent® (alirocumab) in patients with diabetes and hypercholesterolemia. Data from the studies was presented at the recent 77th Scientific Sessions of the American Diabetes Association in San Diego, CA.