- Positive Opinion Based on Supporting Data from HUMIRA Study in Pediatric Patients with Severely Active Crohn's Disease
RUNGIS, France, Oct. 19, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for HUMIRA® (adalimumab) for the treatment of pediatric patients aged six to 17 years with severely active Crohn's disease (CD) who failed, are intolerant to or have contraindications to conventional therapy. Following the CHMP's positive opinion, a final decision from the European Commission is anticipated in the next several weeks. Upon final decision, HUMIRA will be the only biologic in the European Union (EU) for the treatment of pediatric CD offering at-home administration.
Pediatric CD is a chronic, debilitating condition of the gastrointestinal (GI) tract that affects up to 200,000 children worldwide(i,ii) CD most commonly involves the end of the small intestine and the beginning of the large intestine.(iii) In addition to symptoms such as chronic abdominal pain, weight loss and loose stools(i) pediatric CD can affect children in several ways, including potentially contributing to malnutrition, failure to grow and/or delayed puberty.(i,iv)
"Severe pediatric Crohn's disease symptoms can be extremely disruptive to a child's daily life and there are limited treatment options available," said John Medich, Ph.D., divisional vice president, clinical development, Immunology, Abbott. "Abbott is pleased pediatric patients and their caregivers may soon have access to a therapy that can be administered at home to help with the challenges of managing this disease."
Upon final approval, HUMIRA will be 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.
Disease progression in children is different from adults, with children developing complications from CD at a faster rate.(v) CD is especially difficult in the pediatric population due to its disruptive nature during a key time in physical and social development and can limit patients' opportunity to form relationships with peers and participate in regular activities.(i,v,vi,viii) Since there is no known cure for CD, the treatment goal of pediatric CD is to induce and maintain clinical remission, with restoration and preservation of normal growth as additional therapeutic goals.(vii)
The filing was supported by a Phase 3 dosing study, the IMAgINE 1 trial, which evaluated weight-based dosing strategies of HUMIRA to induce and maintain clinical remission in pediatric patients with moderately to severely active CD.(viii)
Globally, uses and prescribing information vary; please refer to the individual country label for complete information.
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.
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.
i Mackner, L (2003). "Review: Psychosocial Issues in Pediatric Inflammatory Bowel Disease" J. Pediatr Psychol. 29 (4): 243-257. http://jpepsy.oxfordjournals.org/content/29/4/243.full Last accessed August 22, 2012.
ii Abbott data on file
iii Cadwell, K (2010) "Virus-Plus-Susceptibility Gene Interaction Determines Crohn's Disease Gene Atg16L1 Phenotypes in Intestine." Cell. 141(7): 1135-1145. http://ac.els-cdn.com/S0092867410005453/1-s2.0-S0092867410005453-main.pdf?_tid=efeb0af04d1578cd43c92e113b3dac8c&acdnat=1341957830_670afce61246dbf0d846749ee4fa4915 Last accessed August 22, 2012.
iv Ballinger, A (2000) "Growth Failure Occurs Through a Decrease in Insulin-Like Growth Factor Which is Independent of Undernutrition in a Rat Model of Colitis." Gut 46:695-700. http://gut.bmj.com/content/46/5/695.full Last accessed October 2, 2012.
v Gouldthorpe, O, et al. (2011) "Biologics in Paediatric Crohn's Disease." Gastroenterology Research and Practice. http://www.hindawi.com/journals/grp/2011/287574/ Last accessed August 22, 2012.
vi "Crohn's Disease in Children and Teens." EMedicine Health. http://www.emedicinehealth.com/crohn_disease_in_children_and_teens/article_em.htm Last accessed August 22, 2012.
vii Escher, J. Treatment of IBD in Childhood: Best Available Evidence. Inflammatory Bowel Disease. 9(1):34–58. http://www.macpeds.com/documents/IBDinchildren.pdf Last accessed August 22, 2012.
viii Hyams, J. (2012) Safety and Efficacy of Adalimumab for Moderate to Severe Crohn's Disease in Children. Gastroenterology;143:365–374 http://www.ncbi.nlm.nih.gov/pubmed/22562021 Last accessed August 22, 2012.