ORENCIA is now marketable in all of the 28 member states included within the European Union. | File photo
+ Regulatory
Amanda Rupp | Sep 10, 2016

EC approves Bristol-Myers Squibb's rheumatoid arthritis treatment ORENCIA

Leaders with the European Commission recently approved of ORENCIA from Bristol-Myers Squibb to treat highly active as well as progressive rheumatoid arthritis in adult patients who have not previously used methotrexate.

With this approval, ORENCIA is now marketable in all of the 28 member states included within the European Union.

ORENCIA’s approval marks the first time that a biologic therapy has received an E.U. indication for MTX-naïve rheumatoid arthritis patients. The approval is established on an MRI assessment of inflammatory and structural studies showing the severity of the disease.

The approval states that an IV or SC injection of ORENCIA can be used for patients. E.C. leaders made this decision from information discovered in two Phase 3 studies.

“Across the globe we remain committed to advancing care for those living with [rheumatoid arthritis],” Brian Gavin, vice president and ORENCIA development lead at Bristol-Myers Squibb, said. “The European Commission’s approval of ORENCIA in the E.U. for MTX-naive [rheumatoid arthritis] patients who have highly active and progressive disease is a testament to Bristol-Myers Squibb’s commitment to advancing the science of earlier identification of patients with progressive RA prior to their suffering debilitating joint damage.”

Rheumatoid arthritis is a chronic, systemic, autoimmune disease that causes the lining of the joins (synovium) to inflame. This results in stiffness, chronic pain, joint damage and swelling.

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