Novartis announces approval of Ilaris as gout treatment in EU
The European Commission approved Ilaris in the treatment of patients with acute gouty arthritis who suffer at least three attacks per year and who cannot be treated with non-steroidal anti-inflammatory drugs, colchicine or repeated courses of corticosteroids. Ilaris is the first biologic approved in the EU in this indication. The treatment is administered in a single, subcutaneous, 150 milligram dose, Pharma Times reports.
The EU's approval is based on data from two Phase III trials and their extensions, which demonstrated that patients treated with Ilaris experienced significantly greater pain relief when compared to the injectable steroid triamcinolone acetonide. The majority of adverse events were mild to moderate incidences of infection.
"(The approval) provides new hope for those debilitated by this excruciating condition," David Epstein, the head of Novartis Pharma, said, according to Pharma Times. "Our vision is to realize the potential of Ilaris wherever interleukin-1 beta plays a key role."
Ilaris is currently approved in more than 60 countries, including Japan, the U.S. and the EU, for the treatment of the rare diseases that make up cryopyrin-associated periodic syndrome. The drug is being investigated in multiple rare inflammatory conditions, but gout is potentially the most lucrative market.