FDA approves Novartis' Ilaris for rare childhood arthritis

Drug approved for SJIA in children ages 2 years and older

EAST HANOVER, N.J. — The Food and Drug Administration has approved a biotech drug made by Novartis for treating a form of arthritis that affects children, the Swiss drug maker said Friday.

Novartis announced the approval of Ilaris (canakinumab) for active systemic juvenile idiopathic arthritis in patients ages 2 years and older. The company said the drug was the first once-per-month drug for injection under the skin to be approved for SJIA. The disease is a rare and disabling form of arthritis characterized by spiking fever, rash and arthritis that can affect children as young as 2 years and continue into adulthood, according to studies. The drug is also approved for treating rare, lifelong and debilitating genetic disorders known as cryopyrin-associated periodic syndromes.

"In the United States, this approval marks the second Ilaris indication for patients living with rare, autoinflammatory conditions," Novartis Pharmaceuticals global head of development Timothy Wright said.


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