CHMP issues positive opinion for Roche RA drug label expansion


The EMA's Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion supporting the approval of Roche's (OTCQX:RHHBY) RoActemra/Actemra (tocilizumab) as as treatment for patients with early rheumatoid arthritis (RA) not previously treated with methotrexate (MTX).

The humanized anti-interleukin 6 receptor antagonist is currently approved for use in combination with or as monotherapy with MTX for the treatment of moderate-to-severe RA in adult patients who have either responded inadequately to or who are intolerant to previous therapy with one or more disease-modifying antirheumatic drugs or tumor necrosis factor antagonists.

A final decision by the European Commission usually takes ~3 months.

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