Ilaris Receives Recommendation For European Approval

Novartis’ Ilaris (canakinumab) has received a recommendation for approval in the EU. The drug is to treat patients with a life-long and potentially fatal auto-inflammatory disease – cryopyrin-associated periodic syndrome (CAPS). The EU submission was supported by data showing that Ilaris, a monoclonal antibody formerly known as ACZ885, produced rapid and sustained remission of symptoms in up to 97% of CAPS patients, with most responding from the first injection.

Ilaris represented an advance in the development of personalized medicines as it targets a condition triggered by a specific genetic mutation, said the company. As Ilaris normalizes the production of IL-1ß, it is also being studied in other diseases in which IL-1ß plays a pivotal role such as systemic juvenile idiopathic arthritis (SJIA), gout, chronic obstructive pulmonary disorder (COPD), and type 2 diabetes.

Trevor Mundel, head of global development at Novartis, said: By concentrating initially on a rare syndrome with a well-defined disease process such as CAPS, we have been able to demonstrate a clear therapeutic advantage with Ilaris. Our focus now is to establish whether this could also provide a new approach to the treatment of other diseases involving a similar underlying process.

A positive opinion recommending the approval of Ilaris for CAPS was issued by the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines for the European Commission.