Novartis gets EU approval for expanded use of Ilaris, acute gouty arthritis

The European Commission (EC) has approved Swiss drug major Novartis’ (NOVN: VX) llaris (canakinumab, ACZ885) in the treatment of patients with acute gouty arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options.

Ilaris is the first biologic approved in the European Union for symptomatic pain relief in a gouty arthritis indication, and is administered in a single, subcutaneous injection of 150mg. Ilaris was launched in the USA and EU in 2009 as a treatment for an auto-inflammatory condition called cryopyrin-associated periodic syndrome (CAPS), said Novartis. The rarity of that condition has meant sales have been relatively small. Gouty arthritis is a much bigger market for the drug and, along with a juvenile arthritis indication Novartis is pursuing, could push Ilaris towards blockbuster status with sales in excess of $1 billion a year.

Ilaris is specifically indicated for the 'symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least three attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.