FDA Expands Use of Rheumatoid Arthritis Drug Arava

The U.S. Food and Drug Administration (FDA) has expanded its approval of the drug Arava® (leflunomide) and has okayed prescribing it to help improve the physical functioning of rheumatoid arthritis patients.

"Rheumatoid arthritis can have devastating effects on a person's ability to carry out daily activities like buttoning a shirt, opening a door and even walking" said Dr. Francois Nader, Senior Vice President, Medical Affairs, of Aventis North America.

"For people with rheumatoid arthritis, demonstrating an improvement in the ability to perform daily activities is an important indicator of treatment success," Nader said. "We believe [this] will reinforce for physicians the clinically meaningful benefits of Arava treatment."

Arava, an oral disease-modifying antirheumatic drug (DMARD), is a first-line therapy increasingly widely used to reduce signs and symptoms of rheumatoid arthritis, and inhibit structural damage and joint space narrowing.

The expanded FDA approval was based on data from three long-term phase III clinical trials that found marked improvement in the physical function of rheumatoid arthritis patients.

Improvement in physical function was assessed on the basis of patients' ability to conduct daily activities (e.g., walking, eating, dressing and washing), their function in daily life, and their sense of well-being.

Other sources: Aventis