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Roche arthritis drug recommended for US approval
30 Jul 2008
Regulatory Affairs
Roche says Actemra has been recommended for approval by the Arthritis Advisory Committee of the US Food and Drug Administration (FDA).
It reveals there was a ten to one vote in favour of recommending the medicine's approval for adults with moderate to severe cases of rheumatoid arthritis (RA).
According to the Swiss drugs giant, in clinical trials the drug was shown to significantly reduce symptoms, regardless of whether other therapies had previously been given.
William Burns, chief executive of Roche's pharmaceuticals division, commented: "We are pleased with the FDA advisory committee's very positive recommendation for Actemra, which helps move this promising new therapy closer to becoming available for patients who suffer from the debilitating symptoms of RA."
He said that the company remains hopeful the treatment will be granted approval by the FDA.
The firm recently revealed in a half-year report that its net income was 5.7 billion Swiss francs (£2.7 billion).
Sales of pharmaceuticals were up by nine per cent during the period.
