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news.The US Food and Drug Administration (FDA) has approved the extension of AbbVie's Humira indication for moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) to reducing signs and symptoms in patients aged two years and older.
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In 2008, Humira was approved in the US for polyarticular juvenile idiopathic arthritis (JIA) in patients aged four years and older.
AbbVie Pharmaceutical Development vice-president Scott Brun said the company is happy that children between the ages of two and four living with polyarticular JIA will now have Humira as an additional treatment option.
"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," Brun said.
The drug will be available to patients aged two years and older living with polyarticular JIA with the dose based on patient weight.
Currently, Humira is available for this patient population in a 10mg pre-filled syringe, 20mg pre-filled syringe, 40mg pre-filled syringe and 40mg Humira auto-injector pen.
Humira is a prescription medicine used to reduce the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adults, polyarticular JIA in children and psoriatic arthritis (PsA) in adults.