Abbott received approval from the FDA to market Humira as a treatment for reducing symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Humira is also indicated for reducing the signs and symptoms and inducing clinical remission in these patients if they no longer respond to or are intolerant to infliximab, the only other approved biologic for treatment of Crohn's disease.
Crohn's disease is a serious chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than one million people in North America and Europe. This approval establishes Humira as the first and only self-administered biologic for the treatment of Crohn's disease. This is the fourth FDA approval in immune-mediated diseases for Humira.
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