The new European approval for the drug allows it to be used as a first-line treatment for severe, active and progressive rheumatoid arthritis, and can be used in adults not previously treated with the standard medication.
Humira was previously approved only for the treatment of moderate to severe, active rheumatoid arthritis in adult patients who had already been treated by the standard treatments, but had not been helped by them.
The drug will be available immediately to patients with psoriatic arthritis in Germany, UK, 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 rheumatoid arthritis 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 Dr Alejandro Aruffo, vice president, Global Pharmaceutical Development and Abbott Bioresearch Center, Abbott. “This is important because the earlier we can treat rheumatoid arthritis with Humira, the better the chances for slowing the progression of the disease.”
A decision regarding the FDA’s approval of Humira for these expanded indications in the US is anticipated by the end of 2005.