Humira approved in EU for Crohn’s disease

Humira is the first self-administered biologic for the treatment of Crohn’s disease and offers an effective and convenient treatment option that can help enable patients to maintain control of their disease, according to the US-based pharmaceutical company. Humira is already approved for Crohn’s disease in the US, and this is the fourth approved indication for Humira in the US and the European Union.

The approval was based on data from three pivotal trials of Humira in more than 1,400 adult patients with moderately to severely active Crohn’s disease. One trial found that of 299 anti-TNF naive patients, 36% and 24% of patients receiving Humira (160mg at week zero followed by 80mg at week two and 80mg at week zero followed by 40mg at week two, respectively) achieved clinical remission at week four compared to 12% treated with placebo.

Adverse events reported by more than 5% of Humira-treated patients with a greater incidence than patients taking placebo include injection site irritation, injection site pain, injection site reaction, nausea, joint pain, inflammation of the nose and pharynx, abdominal pain, headache and fatigue.