Sanofi and Regeneron Pharmaceuticals, Inc. have announced the US Food and Drug Administration (FDA) approval of Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to 1 or more disease modifying antirheumatic drugs (DMARDs). In the US, Kevzara will be marketed by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi, in Tarrytown, NY.
Indication: Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to inhibit IL-6R mediated signaling.
Dosage/administration: Kevzara may be used as monotherapy or in combination with methotrexate(MTX) or other conventional DMARDs. The recommended dosage of KEVZARA is 200 mg once every 2 weeks, administered as a subcutaneous injection.
Adverse effects: Most common adverse reactions are neutropenia, increased ALT, injection site erythema, upper respiratory infections, and urinary tract infections.
Sanofi and Regeneron announce FDA approval of Kevzara® (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients. [news release]. Paris, France, and Tarrytown, NY: Sanofi Genzyme May 22, 2017. http://genzyme.newshq.businesswire.com/press-release/sanofi-and-regeneron-announce-fda-approval-kevzara-sarilumab-treatment-moderately-seve. Accessed May 30, 2017.
Must Reads in FDA Actions
FDA Approves Gloperba Oral Solution for Gout Flares, FirstWord Pharma news release; 2019 Feb 26
FDA Approves Hyrimoz for Chronic Conditions, Sandoz news release; 2018 Oct 31
FDA Approves Subcutaneous Actemra for Active SJIA, PharmaLive news release; 2018 Sep 13
FDA Approves Olumiant for Rheumatoid Arthritis, Eli Lilly, Incyte news release; 2018 Jun 1
FDA Approves Consensi for Osteoarthritis Pain, FirstWord Pharma news release; 2018 May 31