AbbVie gains expanded approval for Humira by FDA
US drugmaker AbbVie (NYSE: ABBV) has received approval from the US Food and Drug Administration for an extension of the approved indications for its blockbuster drug Humira (adalimumab).
Humira was approved in the USA in 2008 for polyarticular juvenile idiopathic arthritis in patients aged four and over, but has now been approved for moderately to severe polyarticular juvenile idiopathic arthritis to reducing signs and symptoms in patients of two years old and over.
It will be available to patients aged two years and over living with polyarticular JIA with the dose based on patient weight. 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.
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