US regulators delay approval of new rheumatoid arthritis drug

Approval for a new rheumatoid arthritis drug has been delayed by the US regulatory body, the Food and Drug Administration (FDA).

Manufacturer Roche said in a statement that the FDA has delayed approval for tocilizumab (brand name Actemra), as the body wants more information on the manufacturing of the drug and other issues like final labelling, but not on safety or efficacy matters. No new clinical trials had been requested by the FDA.

Tocilizumab is an anti-interleukin-6 receptor antibody and works in a different way to the existing class of medicines that block an inflammatory protein called tumour necrosis factor (TNF).

In a clinical trial of 4,000 rheumatoid arthritis patients completed last year, it was found that tocilizumab significantly reduced the disease's symptoms.

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