RoActemra

tocilizumab

Opinion

On 20 September 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product RoActemra. The marketing authorisation holder for this medicinal product is Roche Registration GmbH.

The CHMP adopted a new indication for RoActemra 162 mg solution for injection in pre-filled syringe as follows:

"RoActemra 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. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX."

For information, the full indications for RoActemra 162 mg solution for injection in pre-filled syringe will be as follows:*

"RoActemra, 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, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

RoActemra 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.

RoActemra 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. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.

RoActemra 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.

RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

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

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


* New text in bold

Key facts

Name
RoActemra
Agency product number
EMEA/H/C/000955
International non-proprietary name (INN) or common name
  • tocilizumab
Active substance
  • tocilizumab
Therapeutic area
Arthritis, Rheumatoid
Arthritis, Juvenile Rheumatoid
Date opinion adopted
20/09/2018
Company name
Roche Registration GmbH
Status
Positive
Application type
Post-authorisation

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