Regeneron Pharmaceuticals, Inc., and Sanofi announced that the US Food and Drug Administration (FDA) has approved Kevzara (sarilumab) injection to treat adults with moderate to severe rheumatoid arthritis (RA).
This treatment is recommended in patients with RA who have had an inadequate response or demonstrated intolerance to one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX).
Kevzara®, a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), may be used as monotherapy or in combination with MTX or other DMARDs. The recommended dosage is 200 mg once every 2 weeks in the form of a subcutaneous injection, which can be self-administered. Users can reduce the dosage from 200 mg to 150 mg once every 2 weeks, as needed.
The approval of Kevzara was based on data from approximately 2900 adults with moderate to severe RA with an inadequate response to previous treatment regimens. In 2 Phase 3 clinical trials, Kevzara plus background DMARDs demonstrated statistically significant, clinically meaningful improvements.
In the MOBILITY study, treatment with Kevzara and MTX reduced signs and symptoms, improved physical function, and demonstrated significantly less radiographic progression of structural damage vs placebo and MTX. At Week 24, the Kevzara 200 mg and 150 mg groups had a greater improvement in the primary end point vs placebo as measured by 20% improvement in the American College of Rheumatology 20% improvement (ACR20) criteria (66% and 58% vs 33%, respectively).
In the TARGET study, patients treated with Kevzara and a DMARD had reduced signs and symptoms, and improved physical function vs placebo and a DMARD. At Week 24, the Kevzara 200 mg and 150 mg groups showed a greater improvement in the primary end point vs placebo as measured by achieving an ACR20 response (61% and 56% vs 34%, respectively).
“Today’s approval in the US not only underscores our ongoing commitment to making a difference in the lives of patients, but also demonstrates our drive to accelerate science and medicine in immunology,” Olivier Brandicourt, MD, chief executive officer, Sanofi, said.
Regeneron and Sanofi announce FDA approval of Kevzara® (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients [news release]. Regeneron Pharmaceuticals, Inc: Tarrytown, NY; May 22, 2017. http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-fda-approval-of-kevzara-sarilumab-for-the-treatment-of-moderately-to-severely-active-rheumatoid-arthritis-in-adult-patients-300461766.html. Accessed May 30, 2017.