Bristol-Myers Squibb’s Orencia has been approved in Europe for the treatment of rheumatoid arthritis, and should be available in several countries in the European Union as of June 2007.

Orencia (abatacept) is the first in a class of so-called T cell co-stimulation modulators that alter the way in which the body responds to inflammation, a key factor in RA. Specifically, the drug has been cleared for use in combination with the standard therapy methotrexate for moderate-to-severe active RA in adults intolerant or unresponsive to other therapies.

Commenting on the approval, Beatrice Cazala, President, Europe, Middle East and Africa for Bristol-Myers Squibb, said the drug is “the next generation biologic, and offers physicians a new way of treating patients with rheumatoid arthritis.”

Safe and effective

The drug’s efficacy and safety profile have been studied through a clinical trial program including more than 2,600 patients, which showed that, in combination with methotrexate, Orencia induced significant and sustained improvement in the signs and symptoms of rheumatoid arthritis, including a clinically meaningful improvement in physical function.

“The response we see with Orencia can lead to more active days for rheumatoid arthritis patients, part of our goal to improve all clinical outcomes, including patient well-being,” said Paul Emery, Arc Professor of Rheumatology and clinical director of Leeds Teaching Hospitals Trust.

The global market for RA is sizeable – and around 4.5 million people suffer from the condition in the European Union alone. The costs of inadequately controlled rheumatoid arthritis, which include lost productivity and earnings of patients and caregivers, are a substantial burden, the groups points out, so any new effective therapy could make significant impact.

Orencia was given a US green light in 2005, and generated first-quarter sales of $41 million this year.