Novartis' Ilaris Gets Approval In EU

Published: 28-Oct-2009

To treat children and adults with CAPS

Novarts' biological medicine Ilaris (canakinumab) has been approved in the EU to treat adults and children as young as four years old, with cryopyrin-associated periodic syndrome (CAPS).

Reportedly, the accelerated EU decision follows approvals in the US and Switzerland, where Ilaris was granted priority review in view of the significant unmet medical need.

The company said that the regulatory submission was supported by data showing that Ilaris produced rapid and sustained remission of symptoms in up to 97% of CAPS patients, with most of them responding within hours of the first injection.

Ilaris, previously known as ACZ885, targets and normalises the production of a protein within the immune system called - interleukin-1 beta (IL-1ß).

The CAPS filing was based on a clinical trial program involving more than 100 patients. Data from a pivotal study published in The New England Journal of Medicine showed that Ilaris produced a rapid, complete and sustained response in most patients. None of the patients treated with Ilaris (0 out of 15) experienced a disease outbreak or flare compared to 13 of the 16 patients who received placebo.

The result of the study showed that Ilaris was generally well tolerated and there was no consistent pattern of adverse events apart from a slight increase in infections.

In addition to its orphan drug status for CAPS, Ilaris has been designated as an orphan drug for treating SJIA in the US, EU and Switzerland, and has fast-track status for SJIA in the US.

Joe Jimenez, CEO of pharmaceuticals division at Novartis, said: "We are excited by the latest approval because Ilaris represents a significant therapeutic advance for patients with this debilitating and sometimes fatal disease. 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."

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