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 evaluating efficacy and safety in a range of moderate-to-severe Crohn’s disease patients, from those who were naive to anti-TNF therapy to patients who had previously lost response or were unable to tolerate infliximab. In these trials, Humira demonstrated statistical significance in inducing and maintaining clinical remission.