On 20 July 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tyenne, intended for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA), giant cell arteritis (GCA), CAR-T cell-induced severe or life-threatening CRS and coronavirus disease 2019 (COVID-19)

The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH.

Tyenne will be available as a 20 mg/ml concentrate for solution for infusion and a 162 mg/mL solution for injection. The active substance of Tyenne is tocilizumab, an interleukin inhibitor (ATC code: L04AC07). Tocilizumab is a recombinant humanised anti-human interleukin-6 receptor (IL-6R) monoclonal antibody of the immunoglobulin IgG1 subclass inhibiting soluble and membrane-bound interleukin‑6 receptors implicated in the pathogenesis of different diseases, including inflammatory diseases.

Tyenne is a biosimilar medicinal product. It is highly similar to the reference product RoActemra (tocilizumab), which was authorised in the EU on 16 January 2009. Data show that Tyenne has comparable quality, safety and efficacy to RoActemra. More information on biosimilar medicines can be found here.

The full indication is:

Tyenne 20 mg/mL concentrate for solution for infusion

Tyenne, in combination with methotrexate (MTX), is indicated for:

• the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.
• the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.

In these patients, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Tocilizumab been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.

Tyenne is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

Tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.

Tyenne in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Tyenne is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.

Tyenne 162 mg solution for injection in pre-filled syringe

Tyenne, in combination with methotrexate (MTX), is indicated for:

• the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.
• the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.

In these patients, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.

Tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.

Tyenne in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Tyenne is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.

Tyenne 162 mg solution for injection in pre-filled pen

Tyenne, in combination with methotrexate (MTX), is indicated for

• the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.
• the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.

In these patients, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.

Tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 12 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (see Section 4.2). Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.

Tyenne in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 12 years of age and older, who have responded inadequately to previous therapy with MTX (see Section 4.2).
Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Tyenne is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.”

Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, COVID-19, sJIA, pJIA, CRS, and/or GCA. All patients treated with Tyenne should be given the Patient Alert Card.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.