European Commission Approval For Arava(reg) (Leflunomide) For Use In Adults With Psoriatic Arthritis

Main Category: Arthritis / Rheumatology
Also Included In: Eczema / Psoriasis
Article Date: 23 Jun 2004 - 10:00 PDT


The proven treatment of rheumatoid arthritis, marketed since 1998, also demonstrated efficacy in psoriatic arthritis. Arava is the first oral disease modifying anti-rheumatic drug (DMARD) therapy approved in this indication by the European Commission.

Aventis Europe Press Release

Strasbourg, France - Aventis today announced that the European Commission approved a new indication for Arava (leflunomide): the treatment of adult patients with active psoriatic arthritis (PsA).

Results of clinical studies (pivotal study: TOPAS) demonstrate Arava alone provides decisive advantages in the treatment of PsA: "The product is highly effective in moderating joint and skin symptoms and therefore significantly improves patients' quality of life." explains Gilles Brisson, Head of Aventis Europe, "Moreover the product is well tolerated, easy to use, due to its oral administration route, and cost-effective. These characteristics, make Arava a major treatment option for patients with PsA."

Psoriatic arthritis is a potentially disabling inflammatory disease that affects up to 30% of patients with psoriasis, a skin condition found in about 1-3% of the population. PsA is most probably under diagnosed; therefore the true prevalence may be higher. PsA is associated with significant disability, reducing quality of life and increased mortality. Approved and effective treatment options for patients with PsA are limited. Classic agents used to treat joint symptoms often do little to improve skin lesions and vice versa.

PsA and psoriasis are accompanied by a significant disease burden, affecting both health-related and emotional aspects of a patient's life. Accordingly, improving quality of life is a critical goal for therapeutic agents used to treat PsA. Arava demonstrated significant improvements compared to placebo both in functional status and in skin-related quality of life. The Dermatological Life Quality Index in Arava patients lead to an improvement of skin related quality of life of 24% as compared to the index for psoriatic patients in general.

About Arava�

Arava is indicated for the treatment of adult patients with active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD), a debilitating disease that leads to inflammation in the lining of the joints. It has shown to reduce the signs and symptoms of rheumatoid arthritis, improve physical function and to retard structural damage, such as erosions and joint-space narrowing as evidenced by X-ray. Arava offers once-daily oral dosing and can be used in both early and late stages of the disease. It was launched in the United States in 1998 and is available in over 70 countries, including the EU, Asia and parts of Latin America.

About Aventis

Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of � 16.79 billion, invested � 2.86 billion in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: http://www.aventis.com.

Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report -"Document de R�f�rence"- on file with the "Authorit� des march�s financiers" in France.

Pursuant to Article 7 of the COB Regulation no. 2002-04, this press release was transmitted to the Authorit� des march�s financiers before its release.

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