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Leflunomide approved for psoriatic arthritis in EU

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Leflunomide approved for psoriatic arthritis in EU

Rheumawire

Jun 25, 2004 Zosia Chustecka

London, UK - The European Agency for the Evaluation of Medicinal

Products (EMEA) has approved leflunomide (Arava®, Aventis) for use in

the treatment of psoriatic arthritis. It becomes the first oral

disease-modifying antirheumatic drug (DMARD) to have this indication.

The only other drug approved for use in psoriatic arthritis is the TNF

inhibitor etanercept (Enbrel®, Immunex/Wyeth), which obtained this

indication in the US in 2002 and last year had this indication extended

to include the statement that the drug can prevent psoriatic arthritis

joint damage, as shown radiographically, as previously reported by

rheumawire. The other 2 TNF inhibitors, infliximab (Remicade®,

Centocor/Schering-Plough) and adalimumab (Humira®, Abbott), have also

shown efficacy in psoriatic arthritis, but haven't been approved for

this use as yet.

Leflunomide is already marketed for use in rheumatoid arthritis (RA),

for which its labeling states that it can improve signs and symptoms,

prevent joint damage, and improve physical function.

In a press release announcing the new indication, head of Aventis

Europe, Gilles Brisson, said clinical trials in psoriatic arthritis have

shown that leflunomide is " highly effective in moderating joint and skin

symptoms " and " significantly improves patients' quality of life. "

" Moreover, the product is well tolerated, easy to use due to its oral

administration route, and cost effective, " he commented, adding that

these characteristics make leflunomide a " major treatment option for

patients with psoriatic arthritis. "

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

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