Abbott’s HUMIRA® (Adalimumab) Approved in the European Union for the Treatment of Crohn’s Disease

HUMIRA is the First Self-Administered Biologic Treatment Offering Sustained Disease Remission in Severe Crohn’s Disease

Abbott announced today that it has received marketing authorization from the European Commission for the use of HUMIRA® (adalimumab) as a treatment for severe 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. This announcement follows FDA approval for the Crohn’s disease indication, which Abbott received in February, and is the fourth approved indication for HUMIRA in the United States and the European Union.

Crohn’s disease is a serious, chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than 1 million people in North America and Europe. It affects people of all ages, but it is primarily a disease of young adults, with onset typically before age 40. There is no medical or surgical cure for Crohn’s disease and few treatment options exist for patients suffering with this chronic condition.

“Crohn’s can have a devastating impact on patients, many of whom are young and active, making it difficult to carry out normal day-to-day activities,” said Rod Mitchell, chairman, European Federation of Crohn’s & Ulcerative Colitis Associations. “The unpredictable nature of the disease can seriously impact their quality of life and self-esteem. For the half million people across Europe suffering from Crohn’s, this approval offers hope to help them regain control of their disease.”

Common symptoms of Crohn’s disease include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Complications include intestinal obstruction, fistulas (ulcers that form tunnels to surrounding tissues), and malnutrition. Over the course of their disease, as many as 75 percent of patients with Crohn’s disease will undergo surgery at least once for complications or disease resistant to treatment. Of those who undergo surgery to remove a portion of the intestines (resection), half will experience a relapse within five years.

“After I was diagnosed with Crohn’s, the unpredictable symptoms made working and relationships difficult. I was afraid to leave the house, ” said Rocio Lopez, a HUMIRA clinical trial patient. “With HUMIRA, my Crohn’s symptoms are under control and I have more freedom to live my life.”

“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,” said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott. “For the thousands of people across Europe with Crohn’s disease, HUMIRA represents a new, effective, and convenient treatment option.”

HUMIRA for Crohn’s Disease

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. The CLASSIC I, CHARM and GAIN trials supporting the indication for Crohn’s disease evaluated the efficacy and safety of HUMIRA in a diverse group of moderate to severe adult Crohn’s disease patients, from those who were naive to anti-tumor necrosis factor alpha (TNF-alpha) therapy, to patients who had previously lost response or were unable to tolerate infliximab, an anti-TNF agent for treatment of Crohn’s disease.

In each trial, clinical remission was measured by a Crohn’s Disease Activity Index (CDAI) score of less than 150. CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general well being and other measures.