FDA Approves Tyenne (tocilizumab-aazg) for Multiple Inflammatory Conditions
The FDA has approved Tyenne (tocilizumab-aazg), a biosimilar to tocilizumab, for the treatment of several inflammatory conditions. The approval covers adult patients with moderately to severely active rheumatoid arthritis after inadequate response to DMARDs, giant cell arteritis, active polyarticular and systemic juvenile idiopathic arthritis in patients aged 2 years and older, CAR T cell-induced severe or life-threatening cytokine release syndrome, and hospitalized adults with COVID-19 requiring supplemental oxygen or ventilation. Tyenne is an interleukin-6 receptor antagonist and can be administered intravenously or subcutaneously depending on the indication. This approval provides an additional treatment option for these conditions.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Tyenne (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist. It binds to both soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated signaling.
Tyenne is indicated for: - Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more DMARDs. - Giant Cell Arteritis (GCA): Adult patients with GCA. - Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2 years and older with active PJIA. - Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2 years and older with active SJIA. - Cytokine Release Syndrome (CRS): Adults and pediatric patients 2 years and older with CAR T cell-induced severe or life-threatening CRS. - Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
General: For RA, PJIA, and SJIA, Tyenne may be used alone or with methotrexate; in RA, other non-biologic DMARDs may be used. Do not initiate if ANC <2000/mm3, platelets <100,000/mm3, or ALT/AST >1.5x ULN (for RA, GCA, PJIA, SJIA); for COVID-19, do not initiate if ANC <1000/mm3, platelets <50,000/mm3, or ALT/AST >10x ULN. Doses exceeding 800 mg per infusion are not recommended for RA, CRS, or COVID-19; for GCA, doses exceeding 600 mg per infusion are not recommended.
RA: IV: 4 mg/kg every 4 weeks, increase to 8 mg/kg based on response. SC: <100 kg: 162 mg every other week, increase to every week; ≥100 kg: 162 mg every week.
GCA: IV: 6 mg/kg every 4 weeks with glucocorticoid taper. SC: 162 mg every week (or every other week based on clinical considerations) with glucocorticoid taper.
PJIA: IV: <30 kg: 10 mg/kg; ≥30 kg: 8 mg/kg every 4 weeks. SC: <30 kg: 162 mg every 3 weeks; ≥30 kg: 162 mg every 2 weeks.
SJIA: IV: <30 kg: 12 mg/kg; ≥30 kg: 8 mg/kg every 2 weeks. SC: <30 kg: 162 mg every 2 weeks; ≥30 kg: 162 mg every week.
CRS: IV: <30 kg: 12 mg/kg; ≥30 kg: 8 mg/kg. Alone or with corticosteroids.
COVID-19: IV: 8 mg/kg as a 60-minute infusion.
Trial data not available in label.
Not reported in label.
Tyenne is a biosimilar to tocilizumab, providing an alternative for the treatment of multiple IL-6-mediated inflammatory conditions. It is indicated for RA, GCA, PJIA, SJIA, CRS, and COVID-19.
View Original Abstract ↓
Late-onset rheumatoid arthritis shows higher DAS28 scores and lower remission rates compared to young-onset disease in a meta-analysis
Meta-analysis compares treatment outcomes in older versus younger rheumatoid arthritis patients
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