Abbott Laboratories' Humira approved in EU

Abbott Laboratories has received approval from the European Commission to market Humira (adalimumab), previously known as D2E7, for the treatment of adult rheumatoid arthritis (RA) in Europe.

Initially it will be available in Germany and the UK, and will be rolled out in other EU countries as pricing and reimbursement policies are adopted.

Abbott filed for EU approval in April last year and received a positive opinion from the European Medicines Evaluation Agency (EMEA) in May 2003. The approval was based on data obtained in four controlled clinical trials. In all, 23 trials have been conducted with Humira, involving more than 2,400 RA patients worldwide.

In the ARMADA trial, some patients on 40mg every other week treatment experienced an improvement in RA signs and symptoms as early as one week (22%, 14/63 patients). These studies used the American College of Rheumatology (ACR) scores as evidence of patient response. After four years of treatment, 63% of patients receiving Humira 40mg every other week achieved an ACR 20 response, 50% achieved an ACR 50 response and nearly one in four achieved an ACR 70 response.

Humira is the first human monoclonal antibody available in Europe for RA, and the first TNF-α antagonist approved with an indication for use with methotrexate or as monotherapy. It received approval from the US FDA on December 31, 2002, and since then has been approved in a further nine countries.

Abbott will offer the treatment in specially designed, prefilled syringes so patients do not have to mix and measure the medicine, or leave their homes for treatment. The prefilled syringe features handles and a plunger head designed for use by patients whose hands have been affected by RA.

'The European approval of Humira gives European RA patients a new option to control their disease that has been shown by the clinical data to be effective, safe and patient-friendly,' said Dr Paul Emery, ARC professor of rheumatology, Leeds University and Leeds University Teaching Hospitals Trust, in the UK. 'The administration is also convenient, being self-administered, usually once every other week.'