Swiss drug maker Novartis AG (NVS) said it received approval from the US Food and Drug Administration, or the FDA, for Ilaris to treat active systemic juvenile idiopathic arthritis or SJIA in patients aged 2 years and older. This approval was based on two Phase III trials in SJIA patients, aged 2-19, showing significant improvement in the majority of Ilaris-treated patients.
Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection. According to references, SJIA is a rare and disabling form of childhood arthritis characterized by spiking fever, rash and arthritis that can affect children as young as 2 years old and can continue into adulthood. Ilaris is being investigated in other inflammatory conditions, including several rare diseases for which approved treatment options do not exist.
"In the US, this approval marks the second Ilaris indication for patients living with rare, autoinflammatory conditions," said Timothy Wright, MD, Global Head of Development, Novartis Pharmaceuticals.
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