Tyenne FDA Approval History
Last updated by Judith Stewart, BPharm on March 12, 2024.
FDA Approved: Yes (First approved March 5, 2024)
Brand name: Tyenne
Generic name: tocilizumab-aazg
Dosage form: Injection
Company: Fresenius Kabi USA, LLC
Treatment for: Rheumatoid Arthritis, Giant Cell Arteritis, Polyarticular Juvenile Idiopathic Arthritis, Juvenile Idiopathic Arthritis
Tyenne (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist biosimilar to Actemra used for treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
- Tyenne is indicated for:
- Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
- Adult patients with giant cell arteritis.
- Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
- Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. - FDA approval was based on clinical data that demonstrated that Tyenne is highly similar to Actemra and that there are no clinically meaningful differences between the biosimilar product and the reference product.
- Tyenne is a biosimilar to Actemra and does not have an interchangeability designation.
- Tyenne is not approved for all the same indications as Actemra. Actemra is approved for the same indications as Tyenne, and also for the treatment of systemic sclerosis-associated interstitial lung disease, cytokine release syndrome, and hospitalized adult patients with COVID-19.
- Tyenne is administered by intravenous infusion or subcutaneous injection.
- The Tyenne product label carries a Boxed Warning for the increased risk of serious infections. Warnings and precautions associated with Tyenne include serious infections, gastrointestinal (GI) perforation, hepatotoxicity, laboratory abnormalities, and hypersensitivity reactions. Live vaccines should be avoided.
- Common adverse reactions include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased alanine transaminase (ALT), and injection site reactions.
- Tyenne is the second tocilizumab biosimilar approved in the United States after the approval of Tofidence (tocilizumab-bavi) in 2023.
Development timeline for Tyenne
| Date | Article |
|---|---|
| Mar 7, 2024 | Approval FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to Actemra |
Further information
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