Basic Information
Avtozma
Regulatory Information
EMEA/H/C/006196
February 14, 2025
December 12, 2024
1
April 7, 2025
Company Information
Hungary
1062 Budapest Váci út 1-3. WestEnd Office Building B torony
Celltrion Healthcare Hungary Kft
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Avtozma, 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, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma 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. Avtozma 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. Avtozma 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. Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma 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. Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma 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. Avtozma, 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, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma 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. Avtozma 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. Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma 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. Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients. Avtozma, 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, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma 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. Avtozma 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). Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma in combination with methotrexate (MTX) is indicated for thetreatment of juvenile idiopathic polyarthritis (pJIA; rheumatoidfactor positive or negative and extended oligoarthritis) in patients 12 years of age and older, who have responded inadequately to previous therapy with MTX (see Section4.2). Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.
Overview Summary
Avtozma is a medicine used to treat: - adults with severe rheumatoid arthritis that is getting worse, who have not been previously treated with a medicine called methotrexate; - adults with moderate to severe active rheumatoid arthritis in whom previous treatments with disease modifying anti-rheumatic drugs (DMARDs), such as methotrexate, or medicines known as tumour necrosis factor (TNF) blockers, have not worked well enough or were not tolerated; - children from 2 years of age with active systemic juvenile idiopathic arthritis in whom other treatments (anti-inflammatory medicines called NSAIDs and corticosteroids) have not worked well enough; - children from 1 year of age with juvenile idiopathic polyarthritis in whom treatment with methotrexate has not worked well enough. Avtozma is used in combination with methotrexate for these conditions but it can be used on its own in patients for whom methotrexate is inappropriate. Avtozma is also used to treat: - adults with giant cell arteritis, a disease in which arteries, usually of the head, are swollen; - adults and children from 2 years of age with severe or life-threatening cytokine release syndrome (CRS, a condition that can cause nausea, vomiting, pain and low blood pressure). CRS is a side effect of certain cancer treatments and Avtozma is used for CRS caused by medicines known as chimeric antigen receptors (CAR) T-cell medicines. Avtozma can also be used in adults with COVID-19 who are receiving treatment with corticosteroid medicines by mouth or injection and require extra oxygen or mechanical ventilation (breathing assisted by a machine). Avtozma contains the active substance tocilizumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Avtozma is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Avtozma is RoActemra. For more information on biosimilar medicines, see [here](https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines).