Abbott Laboratories announced that the European Medicines Evaluation Agency (EMEA) has granted a positive opinion for Humira (adalimumab) label extension for reducing the rate of progression of joint damage as measured by X-ray and improving physical function in adults with rheumatoid arthritis (RA), when given in combination with methotrexate. This positive opinion comes seven months after European Commission approval to market Humira and provides new information for physicians and patients as they consider options for treating RA.
In the United States, Humira was approved December 31, 2002, for both reducing signs and symptoms of RA and inhibiting the progression of structural damage. In October 2003, Abbott submitted a supplemental Biologics Licensing Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of Humira to improve physical function in patients with moderately to severely active RA.
The positive opinion from EMEA is based on clinical data from one study with RA patients with a mean disease duration of approximately 11 years that showed a statistically significant difference for change in modified total Sharp score, which assesses bone erosion and joint-space narrowing by looking at patient X-rays. This score was measured at six months, and was maintained at 12 months for patients in the study treated with Humira 40 mg every other week and methotrexate. Improvements were maintained through two years of Humira treatment. Patients receiving Humira and methotrexate demonstrated less radiographic progression at one year than patients receiving methotrexate alone.
Improvements in physical function and quality of life, as measured by a patient's ability to perform normal daily activities, such as getting dressed, walking and climbing stairs, were established and maintained with Humira through two years of Humira treatment in this study.