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CHMP Issues Positive Opinion For Roche (RHHBY) RA Drug Label Expansion


7/28/2014 12:37:19 PM

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On 24 July 2014 , the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal p roduct RoActemra . The marketing authorisation holder for this medicinal product is Roche Registration Ltd . They may request a re - examination of the CHMP opinion, provided that they notify the European Medicines Agency in writing of their intention within 1 5 days of receipt of the opinion.

The CHMP recommended approval of a new indication for treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate .

Detailed conditions for the use of this product wil l 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 the variation to the marketing au thorisation has been granted by the European Commission.

For inf ormation, the full indications for RoActemra will be as follows 2 : RoActemra, in combination with methotrexate (MTX), is indicated for:

• the treatment of severe, active and progressive rheumatoi d 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 - rheu matic 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 o f progression of joint damage as measured by X - ray and to improve physical function when given in combination with methotrexate.

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