Novartis’ acute gouty arthritis drug approved in Europe

The European Commission has approved Novartis’ Ilaris for 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.

llaris (canakinumab, ACZ885) is the first biologic approved in the EU for symptomatic pain relief in a gouty arthritis indication. It is administered in a single, subcutaneous injection.

The drug is indicated for the “symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 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”.

The EC also granted an additional year of data exclusivity to Novartis based on the significant clinical benefit over existing treatments demonstrated for Ilaris.

“The approval of Ilaris for acute gouty arthritis attacks in patients without appropriate treatment options provides new hope for those debilitated by this excruciating condition. Ilaris targets interleukin-1 beta, a key player in gouty arthritis inflammation. Our vision is to realize the potential of Ilaris wherever IL-1 beta plays a key role and available treatment options don’t give patients the help they need,” said David Epstein, Division Head of Novartis Pharmaceuticals.

Novartis is continuing to work with the US FDA to determine the next steps for ACZ885 after the regulatory body asked for more clinical trial data before it could consider approving the product.