AbbVie’s HUMIRA approved in the European Union

AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved an extension of the EC marketing authorization for HUMIRA (adalimumab) for the treatment of polyarticular juvenile idiopathic arthritis (JIA) in children and adolescents aged two to 17 years who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs), expanded from its originally approved label for children aged four to 17 years that was granted by the EC in 2008.

“JIA commonly presents in early childhood between the ages of two to four years, and to date, approved therapeutic options have been limited,” said Daniel Kingsbury, medical director, Pediatric Rheumatology at Randall Children’s Hospital in Portland, Oregon. “The approval of new treatments is very exciting and welcomed news for our patients and their families, as well as for the physicians and the medical teams involved with their care.”

The EC approval for the label extension was supported by a study evaluating the safety and efficacy of HUMIRA in 32 children with moderately to severely active polyarticular JIA aged two to less than four years or aged four and above weighing less than 15 kilograms. This study data showed that HUMIRA was efficacious in this younger patient population. At weeks 12 and 24, 93.5 and 90 percent of patients, respectively, achieved at least 30 percent improvement in the pediatric ACR criteria (PedACR30).

“Ten years after its first approval for moderate to severe active rheumatoid arthritis, HUMIRA is still one of the most comprehensively studied biologics available to patients,” said John R. Medich, Ph.D., divisional vice president, Immunology Clinical Development, Global Pharmaceutical Research and Development, AbbVie. “Polyarticular JIA is particularly disruptive for these young patients. This extension of the indication upholds AbbVie’s ongoing commitment to research that helps meet the needs for patients of all ages around the world.”

JIA is an umbrella term for a group of serious, painful and potentially disabling chronic arthritis conditions that occur before the age of 16 that affect as many as 4 per 1000 children worldwide. Polyarticular JIA is a subtype of JIA that affects five or more joints, and symptoms include painful, swollen and tender joints, limping, morning stiffness, decreased activity and a reluctance to use an arm or a leg. For a young child, these physical symptoms and limitations can have a significant impact on daily life activities. Studies have shown that over one-third of JIA patients have active, ongoing disease into adulthood.

About M10-444

M10-44 is an international, multicenter, open-label study of patients with moderate-to-severe polyarticular JIA in the United States (including Puerto Rico) and the European Union. The study assessed the safety of HUMIRA – given subcutaneously every other week for a minimum of 24 weeks – as measured by the incidence of serious adverse events and adverse events over the course of the study. Patients received 24 mg/m2 body surface area (BSA) of Humira up to a maximum of 20 mg every other week as a single dose via subcutaneous injection for at least 24 weeks. All pediatric patients were aged two to less than four years or aged four years and above weighing less than 15 kilograms.

Results from this study showed that the safety profile of HUMIRA in younger JIA patients aged two to less than four years or aged four and older weighing less than 15 kilograms was similar to that seen in previous clinical trials for Humira. Additionally, HUMIRA was efficacious in this younger JIA patient population, demonstrating PedACR 30/50/70/90 response rates of 94%/90%/61%/39% at 12 weeks and 90%/83%/73%/37% at 24 weeks.

PedACR responses in children with JIA are determined by measuring changes in six core criteria defined by the American College of Rheumatology, which are: the number of joints with active arthritis, the number of joints with limited movement, the physical functioning, the level of inflammation measured by a blood test, the physician’s global assessment of disease activity, and the parent’s assessment of overall child’s well-being. For example, achieving a PedACR 30 means that the child’s disease has improved by 30%.

About HUMIRA (adalimumab)

Uses

HUMIRA in combination with methotrexate is indicated for:

• The treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate and for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate 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 methotrexate.
• The treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged two to 17 years who have had an inadequate response to one or more DMARDs. HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. HUMIRA has not been studied in children aged less than 2 years.

Important Safety Information

HUMIRA is a human monoclonal antibody that binds to tumor necrosis factor alpha (TNF-α). People should not use HUMIRA if allergic to adalimumab or any other ingredients of HUMIRA; have a severe infection including active tuberculosis (TB); or have moderate to severe heart failure.

People may get infections more easily while using HUMIRA. This risk may increase if lung function is impaired. These infections may be serious and include TB, infections caused by viruses, fungi, parasites, bacteria, other opportunistic infections, and sepsis that may, in rare cases, be life-threatening. Cases of TB have been reported in people treated with HUMIRA. People should be checked for both active and inactive TB and hepatitis B virus (HBV) before starting HUMIRA and monitored for signs and symptoms during and after therapy. People should tell their doctor if they live in or have traveled to a region where fungal infections are common; have a history of recurrent infections; or have an increased risk of getting infections. People over 65 years of age may be more susceptible to infections while taking HUMIRA.

There have been cases of certain kinds of cancer in people taking HUMIRA or other TNF blockers. The risk of getting lymphoma, leukemia, or other cancers may increase. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. In addition, cases of non-melanoma skin cancer have been observed in patients taking HUMIRA.

Other possible serious side effects with HUMIRA include reactivation of hepatitis B in chronic carriers of this virus, central nervous system problems, and allergic reactions including anaphylaxis, blood problems, new or worsening congestive heart failure, and certain immune reactions such as lupus like syndrome.

Certain vaccines may cause infections and should not be given while receiving HUMIRA. HUMIRA may have a minor influence on the ability to drive and use machines. The use of HUMIRA with anakinra or abatacept is not recommended.

The most commonly reported adverse reactions include injection site reactions (including pain, swelling, and redness or itching), respiratory tract infections (including a cold, runny nose, sinus infection, or pneumonia), headache, abdominal pain, nausea, vomiting, rash, and musculoskeletal pain.

HUMIRA is given by injection under the skin. The benefits and risks of HUMIRA should be carefully considered before starting therapy.

Globally, prescribing information varies; refer to the individual country product label for complete information.