Abbott’s HUMIRA® (adalimumab) Approved in the European Union

AbbottAbbott (NYSE: ABT) today announced that the European Commission has granted marketing authorization for the use of HUMIRA®, in combination with methotrexate (MTX), as a treatment for active polyarticular juvenile idiopathic arthritis (JIA) in adolescents aged 13 to 17. Additionally, HUMIRA for JIA treatment is approved for those patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs). HUMIRA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. JIA involves five or more joints and is the most common form of arthritis in children worldwide.

HUMIRA is the first new biologic treatment introduced in eight years for patients with JIA and the first to offer a convenient, at-home and self-administered dose every other week. JIA is the first pediatric indication for HUMIRA in Europe and the sixth indication for HUMIRA overall.

JIA usually appears before the age of 16. Symptoms commonly include persistent joint swelling, pain and stiffness. Any joint can be affected and inflammation may limit the mobility of the affected joints. The goal of treatment is to control inflammation, relieve pain, preserve mobility and joint function, as well as prevent disease progression.

About HUMIRA JIA Clinical Study
The European Union approval is based on the results of a Phase III, 48-week study that included 171 children with polyarticular JIA. The 48-week study was followed by an open-label extension period. In the first part of the 48-week study, two groups of patients – those taking MTX and those not taking MTX – received open-label HUMIRA subcutaneously every other week for 16 weeks. Children who showed a 30 percent or greater improvement in JIA signs and symptoms (n=133) entered the second part of the study and were randomized to receive either HUMIRA or placebo for an additional 32 weeks or until disease flare.

In the second part of the study, significantly fewer children receiving HUMIRA demonstrated disease flare compared to children on placebo, both without MTX (43 percent vs. 71 percent, p=0.031) and with MTX (37 percent vs. 65 percent, p=0.015). Twice as many children on HUMIRA achieved PedACR 70 compared to those on placebo (56 percent vs. 28 percent, respectively, p<0.001) at week 48.

Patient responses were measured using the American College of Rheumatology Pediatric (PedACR) 30 score, which represents a 30 percent or greater improvement in JIA signs and symptoms, such as the number of swollen joints with loss of motion, assessment of pain and level of disability. A flare was defined as a worsening of 30 percent or more in at least three of the six PedACR Pedi response variables, a minimum of two active joints, and no more than one indicator improving by 30 percent.

At the end of the 48-week study or at the time of disease flare during the double-blind phase, patients could enter the open-label extension period. Efficacy and safety were assessed at routine intervals throughout the study. PedACR responses were maintained for up to two years in patients who received HUMIRA throughout the study.

The most common adverse events were infections (mostly mild upper respiratory) and injection site reactions. No tuberculosis or serious opportunistic infections were reported during this study. The adverse events observed in children were similar in frequency and type to those observed in adults in previous studies with HUMIRA.

HUMIRA is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), plaque psoriasis, ankylosing spondylitis (AS) and Crohn's disease in the United States and Europe. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-α), a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. To date, HUMIRA has been approved in 76 countries and more than 270,000 patients worldwide are currently being treated with HUMIRA. Clinical trials are underway evaluating the potential of HUMIRA in ulcerative colitis.

In Europe, in addition to its approval for polyarticular JIA, HUMIRA in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including MTX has been inadequate. HUMIRA is also indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. HUMIRA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. HUMIRA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

HUMIRA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. HUMIRA has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.

HUMIRA is indicated for the treatment of adults with severe, active ankylosing spondylitis who have had an inadequate response to conventional therapy.

HUMIRA is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, HUMIRA should be given in combination with corticosteroids. HUMIRA can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.

HUMIRA is indicated for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, MTX or PUVA.

Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The AbbottBioresearchCenter, founded in 1989 in Worcester, Massachusetts, United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases.

About Abbott
Abbott (NYSE: ABT) 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 more than 68,000 people and markets its products in more than 130 countries.