Tyruko®

Understanding Tyruko®
Tyruko® (natalizumab‑sztn) is approved by the U.S. FDA as a biosimilar to Tysabri (natalizumab) for use in adults with relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease) and for inducing and maintaining clinical response and remission in adults with moderately to severely active Crohn’s disease who have had an inadequate response to, or are unable to tolerate, conventional therapies and TNF‑alpha inhibitors. Due to the risk of progressive multifocal leukoencephalopathy (PML), Tyruko® is available only through a restricted distribution program (REMS).

How Tyruko® Works:

• Integrin blockade: Provides targeted immunomodulation by binding the α4‑subunit of α4β1 and α4β7 integrins on leukocytes (except neutrophils), inhibiting α4‑mediated adhesion and limiting leukocyte migration across the endothelium into the central nervous system and gastrointestinal tract.
• Helps reduce MS relapses: By restricting immune cell trafficking into the CNS, Tyruko® decreases inflammatory activity associated with relapsing forms of multiple sclerosis.
• Induces and maintains remission in Crohn’s disease: By blocking leukocyte homing to intestinal tissue, Tyruko® can induce and maintain clinical response and remission in eligible adults with moderately to severely active disease.
• Risk management via REMS: Because natalizumab products increase the risk of PML, Tyruko® is dispensed only under the Tyruko® REMS to ensure prescriber, infusion site, pharmacy, and patient education and monitoring.

FDA Approval:
2023 – Tyruko® gained FDA approval as the first FDA‑approved biosimilar to Tysabri, covering the reference product’s adult indications (relapsing forms of MS and certain adults with Crohn’s disease).

For more information, please visit the Tyruko® patient website. Speak with your healthcare provider to determine if Tyruko® is the right treatment option for you.