FDA approves Tyruko® (natalizumab-sztn), the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis
On August 24, 2023, the US Food and Drug Administration (FDA) approved Tyruko® (natalizumab-sztn) 300 mg/15 mL for injection, developed by Polpharma Biologics. Tyruko is approved as a monotherapy to treat all indications covered by the reference medicine for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease, as well as Crohn’s disease, all in adults.
Tyruko is the first and only FDA-approved biosimilar for relapsing forms of MS.
Keren Haruvi, President North America, Sandoz Inc., said: “Of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market.”
The FDA granted approval based on a robust data package, including analytical, functional and clinical data. The approval is accompanied by labeling with safety warnings and a Risk Evaluation and Mitigation Strategy (REMS).
INDICATIONS
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 progressive multifocal leukoencephalopathy (PML). Therefore, natalizumab is only available through dedicated Risk Evaluation and Mitigation Strategy (REMS) programs. When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefit of TYRUKO is sufficient to offset this risk.
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.
SELECT IMPORTANT SAFETY INFORMATION
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
See full prescribing information for complete boxed warning.
· Natalizumab products increase the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability.
· Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYRUKO.
· Monitor patients, and withhold TYRUKO immediately at the first sign or symptom suggestive of PML.
· Because of the risk of PML, TYRUKO is available only through a restricted distribution program called the TYRUKO REMS Program.
CONTRAINDICATIONS: Patients who have or have had PML. Patients who have had a hypersensitivity reaction to natalizumab products.
WARNINGS AND PRECAUTIONS: Herpes infections: Life-threatening and fatal cases have occurred with herpes encephalitis and meningitis infections. Blindness has occurred in patients developing acute retinal necrosis. Discontinue TYRUKO if these infections occur and treat appropriately. Hepatotoxicity: Significant liver injury, including liver failure requiring transplant, has occurred. Discontinue TYRUKO in patients with evidence of liver injury. Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have occurred. Permanently discontinue TYRUKO if such a reaction occurs. Immunosuppression/Infections: Natalizumab products may increase the risk for certain infections. Monitor patients for development of infections due to increased risk with use of TYRUKO. Thrombocytopenia: Natalizumab products may cause thrombocytopenia. Monitor patients for bleeding abnormalities. Discontinue TYRUKO in patients with thrombocytopenia.
ADVERSE REACTIONS: The most common adverse reactions (incidence ≥10%) with natalizumab in the MS studies were headache, fatigue, arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea NOS, and rash. The most common adverse reactions (incidence ≥10%) in the CD studies were headache, fatigue, upper respiratory tract infections, and nausea.
USE IN SPECIFIC POPULATIONS: Pregnancy: Can cause fetal harm.
This is not the complete list of all the safety information for TYRUKO. Please click to see full Prescribing Information for TYRUKO.