Tyruko FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 5, 2023.

FDA Approved: Yes (First approved August 24, 2023)
Brand name: Tyruko
Generic name: natalizumab-sztn
Dosage form: Injection
Company: Sandoz Inc.
Treatment for: Multiple Sclerosis, Crohn's Disease

Tyruko (natalizumab-sztn) is an integrin receptor antagonist biosimilar to Tysabri, approved for the treatment of multiple sclerosis and Crohn’s disease.

• Tyruko is indicated:
  - as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  - for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α.
• The FDA approval of Tyruko was based on clinical data that demonstrated that Tyruko is highly similar to Tysabri and that there are no clinically meaningful differences between the biosimilar product and the reference product.
• Tyruko is a biosimilar to Tysabri and does not have an interchangeability designation.
• Tyruko is administered by intravenous infusion over one hour, every four weeks.
• The Tyruko product label carries a Boxed Warning for the increased risk of progressive multifocal leukoencephalopathy (PML). Because of the risk of PML, Tyruko is available only through a restricted distribution program called the Tyruko REMS Program.
• Warnings and precautions associated with Tyruko include life-threatening herpes infections, hepatotoxicity, serious hypersensitivity reactions, immunosuppression and increased risk of infections, and thrombocytopenia.
• Common adverse reactions in multiple sclerosis patients include headache, fatigue, arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea NOS, and rash.
  Common adverse reactions in Crohn’s disease patients include headache, upper respiratory tract infections, nausea, and fatigue.
• Tyruko is the first FDA-approved Tysabri biosimilar.

Development timeline for Tyruko

Further information

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