Abbott files for Humira approvals in United States, Europe

By Lisa Kerner

Charlotte, N.C., Sept. 7 - Abbott Laboratories submitted a supplemental Biologics License Application to the Food and Drug Administration and a Type II Variation to the European Medicines Agency seeking approval to market its fully human monoclonal antibody, Humira (adalimumab), as a treatment for moderate-to-severe Crohn's disease.

The chronic inflammatory disease of the gastrointestinal tract affects more than 1 million people in North America and Europe.

Both filings are based on the results of three randomized, double-blind, placebo-controlled, multi-center trials of Humira in more than 1,400 Crohn's disease patients, including those who were naive to anti-TNF therapy and those unable to tolerate infliximab.

Abbott is a broad-based health care company based in Abbott Park, Ill.

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