FDA approved Tyruko (natalizumab) for Relapsing Forms of Multiple Sclerosis and Crohn's DiseaseFDA approved new drug Tyruko for multiple sclerosis and Crohn's disease.

FDA From the archive Source published August 24, 2023 Summary added July 29, 2026 DOI ↗ Editorial oversight: Dr. Ji-eun Park, MD · Brain, Mind & Pain

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Key Takeaway

Consider the risk of PML when initiating Tyruko; ensure benefit outweighs this risk and register in the REMS program.

The FDA has approved Tyruko (natalizumab), an integrin receptor antagonist, for the treatment of relapsing forms of multiple sclerosis (MS) and moderately to severely active Crohn's disease (CD) in adults. For MS, Tyruko is indicated as monotherapy for clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. For CD, it is indicated for inducing and maintaining clinical response and remission in patients with evidence of inflammation who have had an inadequate response to conventional therapies and TNF-alpha inhibitors. The approval is based on efficacy data from prior studies of natalizumab products. Clinicians should be aware that Tyruko increases the risk of PML, a potentially fatal opportunistic infection, and must consider whether the expected benefit outweighs this risk. Prescribers must be registered in the Tyruko REMS program.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Not reported in label.

Indication & Patient Population

Tyruko is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is also indicated 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-alpha.

Dosing & Administration

The recommended dose is 300 mg administered as an intravenous infusion over one hour every four weeks. Do not give as an intravenous push or bolus. The solution must be administered within 4 hours of preparation. Observe patients during all infusions. For the first 12 infusions, observe patients for one hour after infusion completion; for subsequent infusions, observation is per clinical judgment. In Crohn's disease, discontinue if no therapeutic benefit by 12 weeks of induction therapy, or if patients cannot discontinue chronic concomitant steroids within six months of starting therapy.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Tyruko increases the risk of progressive multifocal leukoencephalopathy (PML). Prescribers must be registered in the Tyruko REMS program. In Crohn's disease, Tyruko should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-alpha.

Place in Therapy

Tyruko is a monotherapy option for relapsing forms of MS and for moderately to severely active Crohn's disease after inadequate response to conventional therapies and TNF-alpha inhibitors. The risk of PML requires careful patient selection and monitoring.

The FDA has approved a new drug called Tyruko (natalizumab) for adults with relapsing forms of multiple sclerosis (MS) and moderately to severely active Crohn's disease (CD). For MS, it is used alone for certain types such as clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. For Crohn's disease, it is for patients who have not responded well to other treatments like TNF-alpha inhibitors.

Tyruko works by blocking certain immune cells from reaching the brain and gut, which helps reduce inflammation. The approval is based on studies that showed it can reduce relapses in MS and improve symptoms in Crohn's disease. This gives patients another option, but it is not a cure.

One important thing to know: Tyruko can increase the risk of a serious brain infection called PML. Because of this, doctors must be enrolled in a special safety program called REMS. Patients should discuss the risks and benefits with their healthcare provider.

If you have MS or Crohn's disease, this approval means there is a new treatment available. But it is not right for everyone. Talk to your doctor to understand if Tyruko could be a good choice for your situation.

What this means for you:

Tyruko is a new option for MS and Crohn's, but it carries a risk of serious infection. Talk to your doctor.

Study Details

Study typeFda approval

PublishedAug 2023

View Original Abstract ↓

1 INDICATIONS AND USAGE TYRUKO is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) 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. Natalizumab products increase the risk of PML [see Warnings and Precautions ( 5.1 )] . When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefit of TYRUKO is sufficient to offset this risk. ( 1.1 ) Crohn's Disease (CD) • TYRUKO is indicated 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. ( 1.2 ) Important Limitations: • In CD, TYRUKO should not be used in combination with immunosuppressants or inhibitors of TNF-α. ( 1.2 ) 1.1 Multiple Sclerosis (MS) 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. Natalizumab products increase the risk of PML [see Warnings and Precautions ( 5.1 )] . When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefit of TYRUKO is sufficient to offset this risk. 1.2 Crohn's Disease (CD) TYRUKO is indicated 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. TYRUKO should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α [see Warnings and Precautions ( 5.1 )] .

FDA approved Tyruko (natalizumab) for Relapsing Forms of Multiple Sclerosis and Crohn's DiseaseFDA approved new drug Tyruko for multiple sclerosis and Crohn's disease.

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FDA approved Tyruko (natalizumab) for Relapsing Forms of Multiple Sclerosis and Crohn's DiseaseFDA approved new drug Tyruko for multiple sclerosis and Crohn's disease.

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