Kevzara Approved to Treat Rheumatoid Arthritis
May 23, 2017 – The U.S. FDA approved Kevzara® (sarilumab), manufactured by Sanofi and Regeneron Pharmaceuticals. Kevzara is indicated to treat adults who have moderate-to-severe rheumatoid arthritis (RA) that has not been controlled adequately by previous treatment with other disease-modifying antirheumatic drugs (DMARDs).
Kevzara is a monoclonal antibody that works by blocking interleukin-6, which is associated with inflammation. Recommended dosing is one 200mg subcutaneous (SC) injection once every two weeks, either alone or in combination with methotrexate or other non-biological RA drugs. Labeling for Kevzara carries a boxed warning that patients who use it are at an increased risk of developing infections, including some that may be life threatening.
Sanofi and Regeneron launched Kevzara upon approval. It is available through open distribution.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.