Abbott receives European approval to market Humira

Aug 15 2005

Abbott has announced that it has received approval from the European Commission to market Humira (adalimumab) as a treatment for psoriatic arthritis and early rheumatoid arthritis (RA) in Europe.

"Until today, the options for patients and physicians seeking an effective medication to treat both the joint and skin aspects of psoriatic arthritis were limited," said Serge Steinfeld, M.D., Ph.D., professor of medicine, Erasme University Hospital, Brussels, Belgium. "This approval brings a new option and new hope in treating the potentially devastating physical aspects of a disease that can be accompanied by significant emotional elements."

Humira will be available immediately to patients with psoriatic arthritis in Germany, United Kingdom, Spain, Finland and Denmark. Availability in other European Union countries will occur in subsequent months as each country adopts pricing and reimbursement policies.

"In addition to Humira being approved for psoriatic arthritis, the approval for first-line use in RA opens the door for patients with severe, active and progressive RA to have the opportunity to experience the benefits of Humira earlier in the treatment phase," said Alejandro Aruffo, Ph.D., vice president, Global Pharmaceutical Development and Abbott Bioresearch Center, Abbott. "This is important because the earlier we can treat RA with Humira, the better the chances for slowing the progression of the disease."

The approval for psoriatic arthritis marks the second indication for Humira, while the early RA approval establishes Humira as a first-line treatment for severe, active and progressive RA in adults not previously treated with methotrexate. Humira was previously approved for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying antirheumatic drugs including methotrexate has been inadequate.

A decision regarding the FDA's approval of Humira for these expanded indications in the United States is anticipated by the end of 2005.