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EU approves Ilaris to treat rare condition

Novartis' Ilaris has been approved in the EU for the treatment of cryopyrin-associated periodic syndrome in adults and children over four-years-old

Novartis' Ilaris (canakinumab) has been approved in the EU for the treatment of cryopyrin-associated periodic syndrome (CAPS), a rare debilitating auto-inflammatory disease, in adults and children over four-years-old.

The EU granted an accelerated approval for Ilaris, which follows approvals in the US and Switzerland. The drug received priority review in these countries due to the significant unmet medical need.

Ilaris is a fully human monoclonal antibody given by injection under the skin once every two months. It is the only therapy approved in the EU for young CAPS patients and for patients with neonatal-onset multi-system inflammatory disease (NOMID) –  the most debilitating form of CAPS.

Supporting data showed that Ilaris produced rapid and sustained remission of symptoms in up to 97 per cent of CAPS patients.

Joe Jimenez, CEO of the Novartis Pharmaceuticals Division said: "Ilaris is the outcome of our pathways-driven search for innovative medicines that are tailored to the needs of patients. Initially we studied Ilaris in a very rare disease with a well-understood genetic profile, and now that its efficacy has been proven, we are able to move ahead rapidly with development in other diseases characterised by the same inflammatory process."

Untreated CAPS can cause deafness, bone deformities, erosive joint destruction and even central nervous system damage leading to loss of vision. Around 20 per cent of patients with NOMID die before reaching adulthood.

28th October 2009

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