Amgen Inc and Wyeth Pharmaceuticals announced that the US Food and Drug Administration (FDA) expanded the marketing approval of EnbrelR (etanercept) to include the improvement of physical function in patients with psoriatic arthritis (PsA). The expanded approval was based on significant improvements in physical function as assessed by the disability index of the Health Assessment Questionnaire (HAQ) in a recent clinical trial. Almost 40% of PsA patients taking Enbrel in this study achieved a HAQ score of zero, indicating no functional disability after 24 weeks of therapy. The FDA also approved an update to the Enbrel label to include new radiographic data demonstrating that Enbrel continued to inhibit the progression of joint destruction for 2 years among most PsA patients who received ongoing therapy. Enbrel has now received 10 FDA approvals in five distinct diseases (PsA, moderate-to-severe rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, and moderate-to-severe plaque psoriasis), has been used by more than 280,000 patients worldwide across indications, and now has 12 years of collective clinical experience.
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