AbbVie’s Humira recommended for EU approval in children with Crohn’s

AbbVie has announced that its drug Humira has been recommended for European approval among paediatric patients with Crohn's disease.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for Humira as a treatment for moderate to severely active Crohn's disease in patients from the age of six years upwards.

This indication would cover children who have had an inadequate response to conventional treatments, including primary nutrition therapy and a corticosteroid or immunomodulator, or who are intolerant to or have contraindications for such therapies.

Data from the IMAgINE-1 study have shown that a majority of patients in this category were able to achieve clinical remission with Humira.

Dr Michael Severino, executive vice-president for research and development and chief scientific officer at AbbVie, said: "We look forward to expanding this treatment option, once approved, to help more children with this debilitating illness during a vulnerable time in their lives."

Humira was first approved 13 years ago and is now available in more than 90 countries worldwide, having been used to treat more than 955,000 patients across 13 indications.