ABBOTT SUBMITS APPLICATIONS IN U.S., EUROPE FOR HUMIRA
Abbott announced it has simultaneously submitted a supplemental biologics license application with the FDA and a Type II Variation to the European Medicines Agency seeking approval to market Humira (adalimumab) as a treatment for moderate-to-severe Crohn's disease. Crohn's disease is a serious, chronic inflammatory disease of the gastrointestinal tract that affects more than 1 million people in North America and Europe combined.
The filings are based on the results of three randomized, double-blind, placebo-controlled, multicenter trials. The trials evaluated the efficacy and safety of Humira in a range of moderate-to-severe Crohn's disease patients, from those who were naïve to anti-TNF therapy to patients who had previously lost response or were unable to tolerate infliximab. In these trials, the drug demonstrated statistical significance in inducing and maintaining clinical remission. In the study evaluating the ability of Humira to maintain remission, a proportion of patients in clinical remission were able to discontinue steroid use.
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