Rheumatology Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product RoActemra ( Tocilizumab ).
The CHMP adopted a new indication as follows: RoActemra in combination with Methotrexate ( MTX ) is indicated for the treatment of juvenile idiopathic polyarthritis ( rheumatoid factor positive or negative and extended oligoarthritis ) in patients 2 years of age and older, who have responded inadequately to previous therapy with Methotrexate. RoActemra can be given as monotherapy in case of intolerance to Methotrexate or where continued treatment with Methotrexate is inappropriate.
For information, the full indications for RoActemra will be as follows:
RoActemra, in combination with Methotrexate, is indicated for the treatment of moderate to severe active rheumatoid arthritis 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 Methotrexate or where continued treatment with Methotrexate 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 2 years 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 Methotrexate or where treatment with Methotrexate is inappropriate ) or in combination with Methotrexate.
RoActemra in combination with Methotrexate is indicated for the treatment of juvenile idiopathic polyarthritis ( rheumatoid factor positive or negative and extended oligoarthritis ) in patients 2 years of age and older, who have responded inadequately to previous therapy with Methotrexate.
RoActemra can be given as monotherapy in case of intolerance to Methotrexate or where continued treatment with Methotrexate is inappropriate. ( Xagena )
Source: European Medicines Agency, 2013
XagenaMedicine_2013
