Abbott Submits Applications for Humira in Crohn’s Disease

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Abbott has simultaneously submitted an sBLA with the FDA and a Type II Variation to the EMEA seeking approval to market Humira as a treatment for moderate-to-severe 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 combined. The filings are based on the results of three randomized, double- blind, placebo-controlled, multi-center trials of Humira eva...

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