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FDA Approved Humira for Chron’s Disease

February 28, 2007 By MedNews Leave a Comment

The Food and Drug Administration (FDA) today approved Humira (adalimumab) to treat adult patients with moderately to severely active Crohn’s disease, a chronic inflammatory disease of the intestines, which affects an estimated one million Americans.

Humira is a human-derived, genetically-engineered monoclonal antibody (a protein that can be produced in large quantities in a manufacturing plant). The product acts to reduce excessive levels of human tumor necrosis factor (TNF) alpha, which plays an important role in abnormal inflammatory and immune responses.

The labeling includes a boxed warning about potential serious adverse events.

Source: FDA

Filed Under: Digestive, Drug Approvals, FDA News & Alerts Tagged With: adalimumab, chron's disease, Humira, prescription drugs

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