Friday, June 4, 2004

STUDY INDICATES ARAVA EFFECTIVE FOR TREATING BOTH PSORIATIC ARTHRITIS, PSORIASIS

Aventis SA's Arava (leflunomide) appears to be an effective treatment for psoriatic arthritic and psoriasis, according to results published in the June issue of Arthritis & Rheumatism.

For 24 weeks, 190 patients with psoriatic arthritis, psoriasis and three or more swollen and tender joints received 20 mg/day of Arava or placebo. They could continue taking nonsteroidal anti-inflammatory drugs or corticosteroids if the dosage remained stable during the study and 28 days prior.

The percentage of patients who responded to treatment, according to Psoriatic Arthritis Response Criteria (PsARC), was significantly greater among those who received Arava than those given placebo (58.9 percent vs. 29.7 percent). Arava was also superior to placebo in each of the four PsARC criteria, including joint pain/tenderness score, joint swelling score, physician's global assessment and patient's global assessment.

The proportion of patients who achieved a 20 percent response, as measured by the psoriatic arthritis-modified American College of Rheumatology criteria, was 36.3 percent in the Arava group and 20 percent in the placebo group.

Furthermore, Arava provided a significant improvement in scores on the Psoriasis Area and Severity Index and superior improvements in quality of life relative to placebo.

Tuesday, June 17, 2003

AVENTIS RECEIVES FDA APPROVAL FOR EXPANDED INDICATION OF ARAVA

Aventis SA announced that the Food and Drug Administration approved an expanded indication for its rheumatoid arthritis treatment Arava (leflunomide) for improvement in physical function.

The approval was based on Aventis' Supplemental New Drug Application submitted to the FDA in December 2002.

Data from three long-term Phase III trials indicated a "marked, clinically meaningful improvement" of physical function in patients treated with the drug, Aventis said. These studies previously demonstrated that Arava, an oral first-line therapy, improved rheumatoid arthritis signs and symptoms and slowed structural damage in patients. Efficacy was sustained for two years in patients continuing treatment.

"For people with rheumatoid arthritis, demonstrating an improvement in the ability to perform daily activities is an important indicator of treatment success," said Dr. Francois Nader, senior vice president of medical affairs at Aventis North America.

The FDA also approved revisions and additions to the Arava safety information, including revised liver function and hematology monitoring recommendations.

Shares of Aventis closed at $59.25, up 3.7 percent, or $2.10, in light trading on the New York Stock Exchange.