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Home Industry News Roche applies for approval of new indication for RoActemra

Roche applies for approval of new indication for RoActemra

21st October 2010

Roche has submitted an application to healthcare regulators for approval of a new indication for its arthritis treatment RoActemra.

In association with development partner Chugai, the company has put forward an accelerated assessment application for the drug to be considered as a therapy for systemic juvenile idiopathic arthritis.

This application is based on data from the phase III clinical trial Tender, in which the drug showed its efficacy in improving the signs and symptoms of the condition compared to placebo after three months of treatment.

An application has also been submitted for this new indication in America, with neither the EU nor the US currently having any approved therapies for this disease.

Dr Hal Barron, head of global development and chief medical officer for Roche, said: "With this striking data we hope RoActemra may become a treatment option that benefits children and their families living with this condition every day."

Earlier this year, the National Institute for Health and Clinical Excellence gave a recommendation for RoActemra to be used in combination with methotrexate as a treatment for rheumatoid arthritis sufferers in the UK.ADNFCR-8000103-ID-800133890-ADNFCR

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