Abbott's HUMIRA® (Adalimumab) Approved in Europe for Severe Active Pediatric Crohn's Disease

-- HUMIRA is the First Biologic Approved in the European Union for the Treatment of Pediatric Crohn's, Offering At-Home Administration

-- Approval Marks the Ninth Indication Approved in the European Union of HUMIRA for the Treatment of Immune-mediated Inflammatory Diseases

ABBOTT PARK, Illinois, Nov. 27, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the European Commission has approved HUMIRA® (adalimumab) for the treatment of pediatric patients aged 6 to 17 years with severe active Crohn's disease (CD) who failed, are intolerant to, or have contraindications to conventional therapy. With this approval, HUMIRA becomes the first biologic treatment approved for these patients in more than five years.

Pediatric CD is a chronic, debilitating condition of the gastrointestinal (GI) tract that affects up to 200,000 children worldwide. CD, which is a type of inflammatory bowel disease, most commonly involves the end of the small intestine and the beginning of the large intestine. In addition to symptoms such as abdominal pain, weight loss and diarrhea, pediatric CD can affect children in several ways unique to this age group, including delayed growth and/or puberty.

"Crohn's disease can be particularly difficult in the pediatric population not only because of the disruptive nature of the disease, but also because these patients are in a key physical and social development stage of their lives," said Jeffrey S. Hyams, M.D., head, Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center. "This approval gives physicians and patients an important new option to consider for the treatment of this chronic and debilitating disease."

The approval was supported by the Phase 3 IMAgINE 1 trial, which evaluated two different dosing strategies of HUMIRA to induce and maintain clinical remission in pediatric patients with severe active CD. 

"The availability of HUMIRA for this patient population addresses an unmet need throughout the European Union and reinforces Abbott's long-standing commitment to patients with inflammatory bowel disease," said John Medich, Ph.D., divisional vice president, clinical development, Immunology, Abbott. "With this approval, these young patients and their care providers may now have access to a therapy that can help manage their disease and be administered at home."

About HUMIRA

Globally, uses and prescribing information vary; please refer to the individual country label for complete information.

HUMIRA is indicated for the treatment of severe active Crohn's disease in pediatric patients (6 to 17 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.

Important Safety Information

HUMIRA is a TNF blocker medicine that affects the immune system and can lower the ability to fight infections.

Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB, hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life threatening if treated.

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus, allergic reactions, nervous system problems, blood problems, certain immune reactions, including a lupus-like syndrome, liver problems, and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines.

Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

HUMIRA is given by injection under the skin.

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's website at www.abbott.com.

SOURCE Abbott