AbbVie's HUMIRA® (adalimumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderately to Severely Active Crohn's Disease

NORTH CHICAGO, Ill., Sept. 25, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) has approved HUMIRA^® (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease patients 6 years of age and older when certain other treatments have not worked well enough. This FDA approval represents the eighth indication for HUMIRA in the United States and makes it the first and only biologic treatment approved for use in this patient population that can be administered at home.

"Moderate to severe Crohn's disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives," said Jeffrey S. Hyams, M.D., head, Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center. "The approval of HUMIRA for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease."

Crohn's disease is a type of inflammatory bowel disease (IBD) which commonly involves the end of the small intestine and the large intestine.¹ Crohn's disease can appear at any age, but it is most often diagnosed in adolescents and young adults between 15 and 35 years of age.² In the United States, there are an estimated 38,000 children and teens with Crohn's disease.³ Symptoms of pediatric Crohn's disease are similar to those in adults and can include abdominal pain, weight-loss and diarrhea.² Additionally, when Crohn's disease is diagnosed in childhood, it may be more extensive than when it is diagnosed in adulthood.⁴ Since there is no known cure for Crohn's disease, one of the treatment goals of pediatric Crohn's disease is to induce and maintain clinical remission.^{5, 6}

"Children living with moderate to severe Crohn's disease have limited treatment options and AbbVie is pleased that HUMIRA will now be an available option for many of these patients," said Michael Severino, M.D., executive vice president, Research and Development and chief scientific officer, AbbVie. "This approval underscores our continued commitment to innovate with HUMIRA, both in studying potential new indications to help meet unmet medical needs and in helping to improve the standard of care for patients living with immune-mediated inflammatory diseases like Crohn's disease."

HUMIRA works by inhibiting tumor necrosis factor-alpha (TNF-α) and can be self-administered after proper injection training is received and with appropriate physician monitoring.

In 2012, the European Commission approved HUMIRA for the treatment of pediatric patients 6 to 17 years of age with severe active Crohn's disease who failed, are intolerant to, or have contraindications to conventional therapy.⁷

About IMAgINE-1
The FDA approval was supported by the Phase 3 IMAgINE-1 trial, which evaluated multiple dosing strategies of HUMIRA to induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn's disease for whom certain other treatments have not worked well enough. IMAgINE-1 is the largest multi-center, randomized, double-blind anti-TNF trial in patients 6 to 17 years of age with moderately to severely active Crohn's disease conducted to date.⁸

U.S. Product Information for HUMIRA^® (adalimumab)

Uses⁹

HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
  • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
  • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
  • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
  • Ankylosing spondylitis (AS) in adults.
  • Moderate to severe adult Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. HUMIRA is also used to reduce signs and symptoms and achieve clinical remission in these adults who have also lost response to or are unable to tolerate infliximab.
  • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years and older when certain other treatments have not worked well enough.
• In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.

Important Safety Information⁹

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.
Please click here for the Full Prescribing Information and Medication Guide.

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

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories.  The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases.  AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries.  For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com.  Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

¹ Rabizadeh S, Hyams JS, Dubinsky M. Crohn's disease. In: Wyllie R, Hyams JS, Kay M, eds. Pediatric Gastrointestinal and Liver Disease. 4^th ed. Philadelphia, PA: Elsevier Saunders; 2011:472-489.
² What is Crohn's disease? Crohn's and Colitis Foundation of America website. http://www.ccfa.org/what-are-crohns-and-colitis/what-is-crohns-disease. Accessed Sept.  16,  2014.
³ Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured U.S. population. Dig Dis Sci. 2013;58:519–525.
⁴Grossman AB, Baldassano RN. Inflammatory bowel disease. In: Kliegman  RM, Stanton BF, Schor NF, St. Geme III JW, Behrman RE. Nelson Textbook of Pediatrics. 19th ed. Philadelphia, PA: Elsevier Saunders; 2011:1294-1304.
⁵Escher JC, Taminiau JA, Nieuwenhuis EE, Buller HA, Grand RJ. Treatment of inflammatory bowel disease in childhood: best available evidence. Inflamm Bowel Dis. 2003; 9(1):34-58.
⁶ Rufo PA, Denson LA, Sylvester FA, et al. Health supervision in the management of children and adolescents with IBD: NASPGHAN recommendations. J Pediatr Gastroenterol Nutr. 2012;55(1):93-108.
⁷ Humira [Summary of Product Characteristics], Maidenhead, United Kingdom; AbbVie. September 2014.
⁸Hyams J, Griffiths A, Markowitz J, et al.  Safety and Efficacy of Adalimumab for Moderate to Severe Crohn's Disease in Children. Gastroenterology. 2012;143:365–374.
⁹ Humira Injection [Package Insert]. North Chicago, IL: AbbVie Inc.

SOURCE AbbVie