FDA Approves Avtozma (tocilizumab-anoh) for Multiple Inflammatory ConditionsFDA approves new arthritis and COVID-19 drug Avtozma

Avtozma (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist. It binds to soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated pro-inflammatory signaling.

Avtozma is indicated for: - Rheumatoid Arthritis (RA): Adults with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (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. - COVID-19: Hospitalized adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

Dosing varies by indication and patient weight. For RA, the IV starting dose is 4 mg/kg every 4 weeks, may increase to 8 mg/kg; subcutaneous dosing is 162 mg every other week (or every week for patients ≥100 kg). For GCA, IV dose is 6 mg/kg every 4 weeks; subcutaneous dose is 162 mg weekly (or every other week based on clinical considerations). For PJIA, IV doses are 10 mg/kg (<30 kg) or 8 mg/kg (≥30 kg) every 4 weeks; subcutaneous doses are 162 mg every 3 weeks (<30 kg) or every 2 weeks (≥30 kg). For SJIA, IV doses are 12 mg/kg (<30 kg) or 8 mg/kg (≥30 kg) every 2 weeks; subcutaneous doses are 162 mg every 2 weeks (<30 kg) or weekly (≥30 kg). For CRS, IV dose is 12 mg/kg (<30 kg) or 8 mg/kg (≥30 kg). 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. Do not initiate if ANC, platelet, or liver enzyme thresholds are not met (see Warnings).

Trial data not available in label.

Do not initiate Avtozma in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or ALT/AST above 1.5 times ULN for RA, GCA, PJIA, SJIA. For COVID-19, do not initiate if ANC below 1000 per mm3, platelet count below 50,000 per mm3, or ALT/AST above 10 times ULN. No contraindications are listed in the label.

Avtozma provides an additional IL-6 receptor antagonist option for multiple inflammatory conditions. It may be used alone or with methotrexate in RA, PJIA, and SJIA; in RA, other non-biologic DMARDs may be used. For GCA, it is used with a tapering glucocorticoid course. For CRS, it may be used alone or with corticosteroids. For COVID-19, it is used in hospitalized patients requiring oxygen or ventilation.