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Abbott Receives Positive Opinion from CHMP for HUMIRA Use in Pediatric Crohn's Disease

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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)

Posted-In: News FDA

 

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