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New Drug Approved For the Treatment of Rheumatoid Arthritis

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By News Release • • April 3, 2000

SUMMARY: A new drug, Arava™(leflunomide), is now available in Canada as a treatment for adults with active rheumatoid arthritis. Arava acts by treating the underlying cause of the disease as opposed to just treating symptoms which include joint inflammation, swelling, stiffness and pain. Both doctors and patients are pleased with the results patients experience after receiving treatment with Arava.

ABSTRACT: Aventis Pharma Inc., the Canadian pharmaceutical company of Aventis S.A., announced the launch of Arava™, a novel drug for adults with active rheumatoid arthritis. Arava (leflunomide) acts by treating the underlying cause of the disease as opposed to just treating symptoms which include joint inflammation, swelling, stiffness and pain.

"This is the first specifically-designed DMARD (disease-modifying antirheumatic drug) to come to the market in 10 years and having this new treatment option available is good news for those who are afflicted with this autoimmune disease,'' said Jean Bourgouin, M.D., Vice-President of Scientific Affairs at Aventis Pharma. "We anticipate that patients taking Arava will have a better quality of life, given the drug's ability to slow down the progression of the disease."

Rheumatoid arthritis, characterized by an immune system attack on joint tissues leading to their progressive destruction, affects close to 300,000 people in Canada alone. The disease often attacks adults in their most productive middle years, causing them to lose functional ability. As the disease progresses, the joints may be so deformed as to require reconstructive surgery.
"We're still not where we would like to be when it comes to effective treatments for rheumatoid arthritis," said Dr. Boulos Haraoui, director of clinical research at Montreal's Notre-Dame Hospital's department of rheumatology. "That's why we feel this product represents such a significant add-on to treatments previously available. The best attribute of this drug is that when it works for a patient, it really does its job well. We see very significant improvements in about eight weeks, which is a relatively short period of time."

Dr. Edward Keystone, director of the Centre for Advanced Therapeutic Studies in Arthritis at Toronto's Mount Sinai Hospital, is also a strong believer in the product's benefits to his patients. "I must say that I am impressed with the results I've seen," he said. "There's no doubt that this product fills an unmet need for those patients who are partial or non-responders to the current standard therapy."

According to Dr. Keystone, the majority of patients being treated for rheumatoid arthritis will require an additional agent or replacement therapy as their disease progresses. "This new agent is making a significant difference in people's lives," he said. "My patients are telling me that not only is their pain being controlled but that they are actually feeling much better overall. So, for patients and rheumatologists, this is a welcome addition."

In clinical studies involving more than 1,800 patients worldwide, Arava was shown to be effective as a therapy for long-term use. "The data, as evidenced by X-ray, clearly showed that Arava slows disease progression," said Dr. Bourgouin. Arava was generally well tolerated in these studies with the most common transient side effects being diarrhea, elevated liver enzymes, hair loss and rash. While the cause of rheumatoid arthritis is not known, bacterial or viral infections, genetic markers and/or stress are considered possible risk factors.

Rheumatoid arthritis generally begins with inflammation (redness, warmth and swelling) in the joints, most commonly the wrist and finger joints, but can also affect the elbows, shoulders, neck, jaw, knees, ankles and feet. In some patients, rheumatoid arthritis can quickly attack internal organs, causing serious damage including inflammation of blood vessels, the lungs and the lining surrounding the heart. The disease is approximately three times more common in women than in men.

Source: Aventis Pharma Inc.

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