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Sarilumab information


Sarilumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL-6R
Clinical data
Trade namesKevzara
AHFS/Drugs.comMonograph
MedlinePlusa617032
License data
  • US DailyMed: Sarilumab
Routes of
administration
Subcutaneous
ATC code
  • L04AC14 (WHO)
Legal status
Legal status
  • AU: S4 (Prescription only)
  • CA: ℞-only[2][3]
  • US: WARNING[1]Rx-only
  • EU: Rx-only
Pharmacokinetic data
Bioavailability80%
Metabolismlikely proteases
Elimination half-life21 days (steady-state, estimated)
Identifiers
CAS Number
  • 1189541-98-7 ☒N
ChemSpider
  • none
UNII
  • NU90V55F8I
KEGG
  • D10161 ☒N
Chemical and physical data
FormulaC6388H9918N1718O1998S44
Molar mass144164.28 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Sarilumab, sold under the brand name Kevzara, is a human monoclonal antibody medication against the interleukin-6 receptor.[4] Regeneron Pharmaceuticals and Sanofi developed the drug for the treatment of rheumatoid arthritis (RA), for which it received US FDA approval on 22 May 2017 and European Medicines Agency approval on 23 June 2017.[5]

Development in ankylosing spondylitis has been suspended after the drug failed to show clinical benefit over methotrexate in a phase II trial.[6]

  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
  2. ^ "Arthritis". Health Canada. 8 May 2018. Retrieved 13 April 2024.
  3. ^ "Regulatory Decision Summary for Kevzara". Drug and Health Products Portal. 12 January 2017. Retrieved 13 April 2024.
  4. ^ "Statement On A Nonproprietary Name Adopted By The USAN Council: Sarilumab" (PDF). ama-assn.org. American Medical Association.
  5. ^ "Kevzara: Authorisation details". European Medicines Agency. Retrieved 28 September 2017.
  6. ^ "Sanofi and Regeneron Report Positive Phase 2b Trial Results with Sarilumab in Rheumatoid Arthritis". regeneron.com (Press release). Paris & Tarrytown, New York: Regeneron. July 12, 2011.

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