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Home Industry News Abbott receives CHMP backing for new Humira indication

Abbott receives CHMP backing for new Humira indication

22nd October 2012

Abbott has been granted a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for approval of a new indication of Humira.

The multipurpose drug has been endorsed for EU approval as a therapy for paediatric patients aged six to 17 years with severely active Crohn's disease who failed, are intolerant to or have contraindications to conventional therapy.

Data from the phase III dosing study IMAgINE 1 showed that the treatment was able to induce and maintain clinical remission among sufferers of this disease, which affects around 200,000 children worldwide.

If approved by the European Commission, Humira would become the only biologic paediatric Crohn's therapy available for at-home administration.

Dr John Medich, immunology division vice-president for clinical development at Abbott, said: "Abbott is pleased paediatric 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."

This comes after the drug was ratified in the US for the treatment of moderate to severe ulcerative colitis last month.ADNFCR-8000103-ID-801473378-ADNFCR

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