Singapore, Jun 22, 2009: The US Food and Drug Administration has approved Ilaris (canakinumab) for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but life-long auto-inflammatory disorders with debilitating symptoms and limited treatment options.
The FDA granted priority review to Ilaris based on its potential to meet an important clinical need for patients with CAPS.
CAPS is caused by a single gene mutation that leads to overproduction of interleukin-1 beta (IL-1ß), which causes sustained inflammation and tissue damage. Symptoms, such as debilitating fatigue, rash, fever, headaches, joint pain and conjunctivitis, can be present from birth or infancy, and can occur daily throughout patients' lives. Long-term consequences may be serious and potentially fatal, including deafness, bone and joint deformities, central nervous system damage leading to visual loss, and amyloidosis resulting in renal failure and early death.
"Children and adults affected by these inflammatory diseases have to cope daily with distressing and debilitating symptoms," said Trevor Mundel, Head of Global Development at Novartis Pharma "We are excited about this first Ilaris approval which reflects our commitment to developing innovative treatments that address unmet medical needs, regardless of the size of the patient population."
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