US health care major Abbott Laboratories has received Food and Drug Administration approval to market Humira (adalimumab) as a treatment to reduce signs and symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older.
The approval is based on safety and efficacy results from a clinical study of JIA patients aged four to 17 years. The agent is the first biologic to receive FDA approval for this condition since 1999, and the first to be given by injection in these patients once every two weeks, noted the firm.
"The pain and inflammation caused by JIA can be debilitating for some children, making it hard for them to run, jump, play or participate in other activities with children of their age," said Daniel Lovell, associate director, Division of Rheumatology, Cincinnati Children's Hospital Medical Center. "Humira is an important new treatment that gives physicians and families another option that can ease the symptoms of polyarticular JIA," he added. The condition is the most common chronic rheumatic disease in children with onset before age 16. Typical symptoms include stiffness when awakening, limping and joint swelling.
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