Children with Crohn’s disease in Europe will now have access to Abbott’s Humira following its approval by the European Commission (EC) in a paediatric indication.
The indication is for use of the inject table TNF blocker in patients aged 6 to 17 years with severe active Crohn’s disease (CD) who failed, are intolerant to, or have contraindications to conventional therapy.
It is the latest in a long list of approvals in autoimmune indications for the company’s lead product, and should help boost the drug’s slowing sales, which contributed to flat growth for Abbott during the third quarter of 2012.
According to Abbott, paediatric Crohn’s disease, which is a type of inflammatory bowel disease, affects up to 200,000 children worldwide.
Aside from abdominal pain, weight loss and diarrhoea, which are also found in adults, symptoms specific to children include delayed growth and/or puberty.
“The availability of Humira for this patient population addresses an unmet need throughout the European Union and reinforces Abbott’s long-standing commitment to patients with inflammatory bowel disease,” said Dr John Medich, divisional vice president, clinical development, immunology, Abbott.
“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.”
Humira (adalimumab) is already available in Europe for adults with moderately to severely active Crohn’s disease, as well as a number of inflammatory indications, including rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.
It is by far Abbott’s biggest selling product, recording revenues of $6.56bn during the first nine months of 2012, compared to the next biggest selling drug Trilipx/TriCor (fenofibrate) to treat high levels of cholesterol, which made $1.12bn in the same period.