AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the HUMIRA indication for moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) to reducing signs and symptoms in patients ages 2 and older. HUMIRA was approved in the United States in 2008 for polyarticular juvenile idiopathic arthritis (JIA) in patients ages 4 and older.
“AbbVie is pleased that children between the ages of 2 and 4 living with polyarticular JIA will now have HUMIRA as an additional treatment option,” said Scott Brun, M.D., vice president, Pharmaceutical Development, AbbVie. “This approval represents AbbVie’s continued commitment to making HUMIRA available to address the needs of patients living with a wide range of immune-mediated diseases.” JIA is the most common form of childhood arthritis. Polyarticular JIA, which occurs in approximately 25 percent of all JIA patients, is one of seven types of JIA, and involves five or more joints. Symptoms include painful, swollen and tender joints, limping, morning stiffness, decreased activity and the reluctance to use an arm or leg.
Early diagnosis and appropriate management of JIA are important in managing this chronic disease.
HUMIRA will be available to patients ages 2 and older living with polyarticular JIA with the dose based on patient weight. HUMIRA is available for this patient population in a 10 mg pre-filled syringe, 20 mg pre-filled syringe, 40 mg pre-filled syringe and 40 mg HUMIRA auto-injector pen.
In the European Union, HUMIRA was approved in 2008 for the treatment of children and adolescents ages 4 to 17 years living with polyarticular juvenile idiopathic arthritis and in 2013 the age range was expanded to patients ages 2 to 17.
