Abbott announces EU Humira approval

Abbott has announced that Humira (adalimumab) has received marketing approval from the European Commission for use in the European Union as a treatment for severe Crohn’s disease.

This approval follows the presentation of data from three pivotal clinical trials of the compound in over 1,400 moderate to severely active Crohn’s disease patients. The Classic I, Charm and Gain trials supported this indication in a range of patients with Crohn’s disease.

Humira operates by blocking tumour necrosis factor alpha, a protein that plays a key role in the inflammatory response of the body to autoimmune conditions when produced in excess.

The compound is currently approved in the EU as a treatment for ankylosing spondylitis, psoriatic arthritis and rheumatoid arthritis.

Eugene Sun, vice-president of global pharmaceutical clinical development at Abbott, said: “The approval of Humira in Crohn’s disease means that an underserved patient population now has a clinically effective treatment option that they can administer themselves.”

He added that this approval of Humira provides a novel, convenient and effective new treatment option for Crohn’s disease patients in Europe.

Last month, at the annual meeting of Digestive Disease Week, Abbott presented data from a clinical study analysis of individuals with Crohn’s disease showing that patients administered with Humira experienced less disease-related hospitalisations than those receiving placebo.