KEVZARA (sarilumab) has been on the market for over 7 years, specifically since its FDA approval on May 22, 2017.
Sanofi and Regeneron announced the FDA approval of Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) on this date. This approval marked a significant milestone for patients seeking new treatment options for this chronic inflammatory condition.
Key Approval Information for KEVZARA
Kevzara's journey to market involved extensive clinical trials to demonstrate its efficacy and safety. Its approval provided a new biologic option for patients who had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate.
Milestone | Date |
---|---|
FDA Approval | May 22, 2017 |
What is KEVZARA?
KEVZARA is a human monoclonal antibody that targets the interleukin-6 (IL-6) receptor. IL-6 is a cytokine that plays a role in the inflammatory immune response often overactive in autoimmune diseases like rheumatoid arthritis. By blocking the IL-6 receptor, Kevzara helps to reduce inflammation and slow the progression of joint damage in RA patients.
- Mechanism of Action: Blocks the IL-6 receptor, interfering with the inflammatory pathway.
- Primary Indication: Moderately to severely active rheumatoid arthritis in adult patients.
- Administration: Administered via subcutaneous injection.
Since its initial approval for rheumatoid arthritis, its availability has provided rheumatologists and patients with another targeted therapy option within the growing landscape of biologic treatments for autoimmune diseases.