FDA News

FDA Approves Labeling Update For ORENCIA To Inhibit Structural Joint Damage In Adults With Moderate To Severe Rheumatoid Arthritis

(April 29, 2007)-- Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has approved an update to the ORENCIA (abatacept) product labeling regarding the progression of structural joint damage -- an important measure in the treatment of rheumatoid arthritis (RA). The indication was strengthened from "slowing" to "inhibiting" the progression of structural damage in adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying, anti-rheumatic drugs (DMARDs), such as methotrexate (MTX) or tumor necrosis factor (TNF) antagonists.

ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active RA who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.

ORENCIA, which was first approved on December 23, 2005, is a selective co-stimulation modulator of a signal required for full T-cell activation and works in a fundamentally different way than cytokine antagonists, including TNF antagonists.

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