FDA Approves Tyenne (tocilizumab-aazg) for Multiple Indications Including RA and COVID-19
The FDA has approved Tyenne (tocilizumab-aazg), a biosimilar to tocilizumab, for the treatment of several inflammatory conditions and COVID-19. The approval covers adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs), as well as adult patients with giant cell arteritis. Additionally, Tyenne is indicated for pediatric patients aged 2 years and older with active polyarticular or systemic juvenile idiopathic arthritis, and for adults and pediatric patients aged 2 years and older with CAR T cell-induced severe or life-threatening cytokine release syndrome. For COVID-19, Tyenne is approved for hospitalized adult patients receiving systemic corticosteroids who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. This approval provides an additional treatment option for these serious 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 of age and older with active PJIA. - Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2 years of age and older with active SJIA. - Cytokine Release Syndrome (CRS): Adults and pediatric patients 2 years of age 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.
For RA, PJIA, and SJIA, Tyenne may be used alone or in combination with methotrexate; in RA, other non-biologic DMARDs may be used. Dosing varies by indication and route (IV or SC). For RA, recommended IV starting dose is 4 mg/kg every 4 weeks, increasing to 8 mg/kg based on response; SC dose is 162 mg every other week (or weekly for patients ≥100 kg). For GCA, IV dose is 6 mg/kg every 4 weeks; SC dose is 162 mg weekly (or every other week based on clinical considerations). For PJIA, IV dose is 10 mg/kg (patients <30 kg) or 8 mg/kg (≥30 kg) every 4 weeks; SC dose is 162 mg every 3 weeks (<30 kg) or every 2 weeks (≥30 kg). For SJIA, IV dose is 12 mg/kg (<30 kg) or 8 mg/kg (≥30 kg) every 2 weeks; SC dose is 162 mg every 2 weeks (<30 kg) or every week (≥30 kg). For CRS, IV dose is 12 mg/kg (<30 kg) or 8 mg/kg (≥30 kg) alone or with corticosteroids. For COVID-19, IV dose is 8 mg/kg as a 60-minute infusion. 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.
Trial data not available in label.
For RA, GCA, PJIA, and SJIA, it is recommended that Tyenne not be initiated in patients with ANC below 2000/mm³, platelet count below 100,000/mm³, or ALT/AST above 1.5 times ULN. For COVID-19, it is recommended not to initiate in patients with ANC below 1000/mm³, platelet count below 50,000/mm³, or ALT/AST above 10 times ULN.
Tyenne is a biosimilar to tocilizumab, providing an alternative for patients requiring IL-6 receptor blockade across multiple indications including 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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