Sanofi and Regeneron announced that the Food and Drug Administration (FDA) has approved Kevzara (sarilumab) injection for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs) such as methotrexate.
Kevzara, an interleukin-6 (IL-6) receptor antagonist, may be used alone or in combination with methotrexate or other DMARDs. Its approval was supported by data from two Phase 3 trials that evaluated approximately 2,900 adults with moderately to severely active RA with inadequate response to previous treatment regimens. In the studies, Kevzara + background DMARDs led to statistically significant, clinically meaningful improvements in patients with moderately to severely active RA.
In the MOBILITY study, patients treated with Kevzara + methotrexate had reduced signs and symptoms, improved physical function, and significantly less radiographic progression of structural damage vs. patients treated with placebo + methotrexate. At Week 24, the Kevzara 200mg and 150mg groups had a greater improvement in the primary endpoint vs. placebo as measured by 20% improvement in the ACR20 criteria (66% and 58% vs. 33%, respectively).
In the TARGET study, patients treated with Kevzara + DMARD had reduced signs and symptoms and improved physical function vs. placebo + DMARD. At Week 24, the Kevzara 200mg and 150mg groups had a greater improvement in the primary endpoint vs. placebo as measured by achieving the ACR20 response (61% and 56% vs. 34%, respectively).
The most common adverse reactions seen with Kevzara are neutropenia, increased alanine aminotransferase, injection site erythema, upper respiratory infections, and urinary tract infections.
Kevzara is available as a 150mg/1.14mL or 200mg/1.14mL strength solution in single-dose prefilled syringes in 2-count packs.
For more information call (800) 633-1610 or visit Kevzara.com.