Product Description
Sarilumab (Kevzara®), a monoclonal antibody against the interleukin-6 (IL-6) receptor, is approved in various countries, including the USA, those of the EU, and Japan, as a subcutaneous treatment administered every 2 weeks for moderately to severely active rheumatoid arthritis (RA) in adults who have responded inadequately to, or are intolerant of, one or more DMARDs (Sourced from: https://pubmed.ncbi.nlm.nih.gov/29931592/)
Mechanisms of Action: IL6 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Subcutaneous,Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Austria | Belgium | Canada | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Russia | Saudi Arabia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Bulgaria, Canada, Chile, Czech Republic, Finland, France, Germany, Ireland, Italy, Mexico, Netherlands, Poland, Russia, Spain, United Kingdom, United States
Active Clinical Trial Count: 5
Highest Development Phases
Phase 2: Arthritis, Juvenile|COVID-19|Pneumonia
Phase 1: Lung Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| DRI13926 | P2 |
Unknown Status |
Arthritis, Juvenile |
2029-02-19 |
|
| SKYPS | P2 |
Recruiting |
Arthritis, Juvenile |
2026-04-01 |
|
| NCT05704634 | P1 |
Recruiting |
Lung Cancer |
2026-01-01 |
|
| SKYPP | P2 |
Completed |
Arthritis, Juvenile |
2022-04-08 |