Abbott Laboratories has bagged a ninth approval for its blockbuster Humira in the European Union since the TNF blocker's first approval in 2003.
The European Commission has given the green light to Humira (adalimumab) for the treatment of paediatric patients aged six to 17 years with severe active Crohn’s disease who have failed conventional therapy, such as maintaining proper nutrition, a corticosteroid and an immunomodulator. With this approval, it becomes the first biologic treatment for these patients in more than five years.
The thumbs-up was supported by the Phase III IMAgINE 1 trial, which evaluated two different doses of Humira to induce and maintain clinical remission in children with severe active CD. The chronic, debilitating condition of the gastrointestinal tract affects up to 200,000 children worldwide and in addition to symptoms such as abdominal pain, weight loss and diarrhoea, Abbott noted that paediatric CD can affect them "in several ways unique to this age group, including delayed growth and/or puberty".
John Medich, head of clinical development at Abbott's immunology division, said that 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 is given by injection under the skin.
Humira is approved for a wide range of immune-mediated inflammatory diseases, such as rheumatoid arthritis, Crohn's in adults, ulcerative colitis and psoriasis. This ninth approval will boost its already-stellar sales which reached $2.33 billion (+10.1%) in the third quarter.