FDA approved Tyenne (tocilizumab-aazg) for Multiple Indications Including RA and COVID-19FDA approved new biosimilar drug Tyenne for arthritis and COVID-19

FDA From the archive Source published March 14, 2025 Summary added May 22, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway

Consider Tyenne as a biosimilar option for IL-6 receptor antagonism in RA, GCA, PJIA, SJIA, CRS, 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)

Mechanism of Action

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.

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

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.

Place in Therapy

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.

The FDA has approved a new drug called Tyenne (tocilizumab-aazg) for several serious health conditions. Tyenne is a biosimilar, which means it is highly similar to an already approved biologic drug and works the same way. It is used to treat inflammatory conditions like rheumatoid arthritis, giant cell arteritis, and certain types of juvenile arthritis. It is also approved for a severe side effect of some cancer treatments called cytokine release syndrome, and for hospitalized adults with COVID-19 who need oxygen or a breathing machine.

Tyenne is for adults with rheumatoid arthritis who have not responded well to other treatments, and for adults with giant cell arteritis. For children ages 2 and older, it can treat active polyarticular or systemic juvenile idiopathic arthritis. For COVID-19, it is for hospitalized adults who are also receiving steroids and need extra oxygen or help breathing.

This approval gives patients and doctors another option for treating these serious conditions. Biosimilars can sometimes be more affordable, but that is not guaranteed. If you or a loved one has one of these conditions, talk to your doctor about whether Tyenne might be a good choice for you. Your doctor can help you understand the benefits and risks based on your personal health situation.

What this means for you:

Tyenne is a new biosimilar option for several inflammatory conditions and COVID-19. Talk to your doctor to see if it is right for you.

Study Details

Study typeFda approval

PublishedMar 2025

View Original Abstract ↓

1 INDICATIONS AND USAGE TYENNE® (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) • Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) ( 1.2 ) • Adult patients with giant cell arteritis. Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( 1.3 ) • Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) ( 1.4 ) • Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Cytokine Release Syndrome (CRS) ( 1.5 ) • Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome. Coronavirus Disease 2019 (COVID-19) ( 1.6 ) • Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). 1.1 Rheumatoid Arthritis (RA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). 1.2 Giant Cell Arteritis (GCA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of giant cell arteritis (GCA) in adult patients. 1.3 Polyarticular Juvenile Idiopathic Arthritis (PJIA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. 1.4 Systemic Juvenile Idiopathic Arthritis (SJIA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. 1.5 Cytokine Release Syndrome (CRS) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older. 1.6 Coronavirus Disease 2019 (COVID-19) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

FDA approved Tyenne (tocilizumab-aazg) for Multiple Indications Including RA and COVID-19FDA approved new biosimilar drug Tyenne for arthritis and COVID-19

Study Details

Evaluating the Efficacy of Traditional Chinese Medicine Decoctions for Rheumatoid Arthritis Management

Traditional Chinese medicine decoctions may improve rheumatoid arthritis symptoms

Clinical research that matters. Delivered to your inbox.

FDA approved Tyenne (tocilizumab-aazg) for Multiple Indications Including RA and COVID-19FDA approved new biosimilar drug Tyenne for arthritis and COVID-19

Study Details

Evaluating the Efficacy of Traditional Chinese Medicine Decoctions for Rheumatoid Arthritis Management

Traditional Chinese medicine decoctions may improve rheumatoid arthritis symptoms

Clinical research that matters. Delivered to your inbox.

Related in Rheumatology

From Other Specialties