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Home Industry News Abbott’s Humira receives paediatric Crohn’s disease approval

Abbott’s Humira receives paediatric Crohn’s disease approval

28th November 2012

Abbott has been granted European regulatory approval for its drug Humira to be used as a therapy for severe active paediatric Crohn's disease.

The European Commission has ratified the therapy for use among patients aged between six and 17 years who failed, are intolerant to or have contraindications to conventional therapy.

Humira is the first biologic treatment approved for this patient group in more than five years, with positive safety and efficacy data from the phase III IMAgINE 1 supporting the decision.

Crohn's is an inflammatory bowel disease that can be particularly difficult to treat among younger sufferers, due to the disruption it can cause during a key period of physical and social development.

Dr John Medich, vice-president for clinical development at Abbott's immunology division, said: "With this approval, these young patients and their care providers may now have access to a therapy that can help manage their disease and be administered at home."

Last month, the company reported data from another Humira analysis, demonstrating that it can deliver clinically meaningful rates of mucosal healing for ulcerative colitis patients.ADNFCR-8000103-ID-801496318-ADNFCR

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