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Humira gets FDA nod for paediatric Crohn's disease

Can be used as treatment for patients as young as six

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The US FDA says AbbVie's Crohn's disease therapy Humira can now be used to treat patients as young as six, two years after it was given the green light for this use in Europe.

Humira (adalimumab) has been approved in the US as a second-line therapy for paediatric Crohn's disease - after the failure of drugs such as corticosteroids or immunosuppressants such as methotrexate.

The subcutaneously-administered drug is the "first and only biologic treatment approved for use in this patient population that can be administered at home," according to AbbVie, which notes it can be self-administered after proper injection training is received and with appropriate physician monitoring.

Johnson & Johnson's Remicade (infliximab) is already approved to treat Crohn's in children aged six years and above but needs to be given in a healthcare facility as it is delivered via intravenous infusion.

Inflammatory bowel disease (IBD) - a collective term for Crohn's disease and ulcerative colitis - affects around 100,000 children in the US, accounting for around 7% of all IBD cases in the country and 10% of all new Crohn's diagnoses. Symptoms include frequent diarrhoea, stomach cramps, fevers and weight loss.

The cause of Crohn's in children is not fully understood but seems to be partially genetic - about 30% of children with Crohn's disease have a close family member who also has the disease - but also seems linked to immunological and environmental factors.

Digestive disease specialist Jeffrey Hyams, of Connecticut Children's Medical Centre in the US, commented: "Moderate to severe Crohn's disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives."

"The approval of Humira for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease," he added.

The FDA has granted Humira orphan drug status for paediatric Crohn's disease and - despite the relatively low number of patients involved - the new indication will add to the product's recent buoyant performance in the gastroenterology sector which is gaining traction as sales in other indications such as rheumatoid arthritis start to slow down.

Humira remains AbbVie's biggest-selling product with sales surging 22% to nearly $6bn in the first half of the year, accounting for two-thirds of its total turnover.

The company's reliance on Humira has been a source of concern and one of the drivers of its $55bn acquisition of Shire, although the recent moves by the US Treasury to clamp down on tax inversion-led M&A has raised questions about the deal.

Article by
Phil Taylor

26th September 2014

From: Sales



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