Novartis recently announced that its drug Ilaris has received approval by the European Commission for the treatment of patients with acute gouty arthritis who suffer from frequent attacks and cannot or should not manage their symptoms with the current treatment options.
The drug is the first biologic that has been approved in the EU for symptomatic pain relief in patients with gouty arthritis. The drug is indicated to be administered in a single, subcutaneous injection of 150 mg. The EU has approved Ilaris specifically for the symptomatic treatment of adult patients with at least three attacks in the previous 12 months who are contraindicate, do not tolerate, or do not have an adequate response to non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine, as well as patients who repeated courses of corticosteroids are not appropriate.
After Novartis’ Ilaris demonstrated significant clinical benefit over existing treatments, the EC granted the company with an additional year of data exclusivity.
“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,” David Epstein, Division Head of Novartis Pharmaceuticals stated. “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.”
Gouty arthritis, commonly known as gout, is a serious, chronic and progressive inflammatory disease that affects 1-4 percent of adults. The inflammation is in response to uric acid crystals forming in the affected joint, which often occurs in the toe, foot, ankle, or knee.
Last Updated: 3/5/13; 11:30AM EST