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Home Industry News Roche granted EU approval for new RoActemra indication

Roche granted EU approval for new RoActemra indication

11th June 2010

Roche has had the licence of its drug RoActemra extended by the European Commission (EC) to cover a new indication for rheumatoid arthritis (RA) patients.

The EC has ruled that the treatment can be specified for use in reducing the rate of progression of joint damage and improving physical function among RA sufferers, when used in conjunction with methotrexate.

This decision comes on the back of positive results from the recent Lithe phase III clinical trial, during which the treatment regimen demonstrated its efficacy over a two-year period.

It also comes after the European Medicines Agency’s Committee for Medicinal Products for Human Use granted a recommendation for approval of the new indication last month.

Dr Hal Barron, executive vice-president of global development and chief medical officer at Roche, described the approval as “great news for patients”.

He added: “This licence extension is based on robust phase III data which not only demonstrates joint damage inhibition but consistently demonstrates high signs and symptoms remission rates across a range of RA patient types.”

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