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CHMP recommends rheumatoid arthritis drug
24 Nov 2008
Regulatory Affairs
Roche has said that the European Committee on Human Medicinal Products has issued a positive recommendation regarding the use of RoActemra in the treatment of rheumatoid arthritis.
The positive opinion relates to the use of the product in combination with methotrexate in adults with moderate to severe forms of the condition who have not benefited adequately from a disease-modifying anti-rheumatic drug or a tumour necrosis factor antagonist.
According to the Swiss drugs giant, RoActemra is a first-in-class therapy representing a novel approach to the treatment of the condition.
"Today’s positive opinion by the European authorities for the approval of RoActemra for rheumatoid arthritis is an important step forward in the fight against this debilitating disease," remarked William Burns, chief executive officer of the company's pharmaceuticals division.
He said that the firm will work closely with regulatory authorities as part of its attempts to get the "groundbreaking" drug to patients "as quickly as possible".
Roche recently announced a change to its senior management.
From January 1st, Per-Olof Attinger will take on the role of head of corporate communications and will become a member of the enlarged corporate executive committee.
