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EC approves new indication for RA drug

Bristol-Myers Squibb's Orencia has been approved in combination with methotrexate for earlier use in the treatment of rheumatoid arthritis

The European Commission (EC) has approved Bristol-Myers Squibb's (BMS) Orencia (abatacept) in combination with methotrexate (MTX) for earlier use in the treatment of moderate to severe active rheumatoid arthritis (RA).

The drug can now be used in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a tumour necrosis factor-alpha (TNF-a) inhibitor.

"This is a very welcome decision from the European Commission and one which will potentially have a positive impact on treatment outcomes for RA patients who have already experienced inadequate response to a first DMARD," said Dr Manuela Le Bars, European medical lead for immunoscience at BMS.

"There is a growing body of evidence to show that earlier use of Orencia may have significant benefits for patients - for both short-term and long-term efficacy. This new indication means patients have the potential to benefit sooner from incremental improvements in function and quality of life provided by Orencia."

The approval was supported by data from a two-year open-label study from a trial in MTX- naïve RA patients (AGREE), as well as by long-term open-label data from the core RA clinical trial programme in MTX inadequate responders (IR) (AIM, ATTEST and a phase IIb study) and in anti-TNF-IRs (ATTAIN and ARRIVE).

These data indicated that Orencia may provide improved outcomes in short-term efficacy as well as durable and sustained long-term efficacy (up to seven years in the phase IIb study) when used with MTX earlier in RA treatment. In addition, a sustained reduction in the rate of progression of structural damage up to five years was demonstrated in the AIM trial.

"Control of the disease in all its aspects is the goal of treatment in RA," said Prof Rene Westhovens, of the University of Leuven in Belgium. "As with other DMARDs, Orencia has the potential to help patients reach a state of remission. The expanded indication of Orencia into an earlier line of RA treatment is part of the wider evolution of RA management that will increasingly allow us to slow the progression of the disease."

RA is a systemic, chronic, autoimmune disease characterised by inflammation in the lining of joints (or synovium), causing joint damage with chronic pain, stiffness and swelling. It limits range of motion and decreased function through affected joints losing their shape and alignment and is thought to affect up to seven million people in Europe.

7th July 2010

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