Novartis is celebrating after getting the green light for Ilaris from European regulators for patients suffering from gouty arthritis.
The European Commission has approved llaris (canakinumab) in the treatment of patients with acute gouty arthritis who suffer frequent attacks (at least three in a year), and who cannot be treated with non-steroidal anti-inflammatory drugs (NSAIDs), colchicine or repeated courses of corticosteroids. It is the first biologic approved in the EU in this indication, and is administered in a single, subcutaneous injection of 150mg.
The approval is based on data from two Phase III trials and their extensions, which showed that patients treated with Ilaris experienced significantly greater pain relief compared to the injectable steroid triamcinolone acetonide. The majority of adverse events, notably infections, were mild to moderate.
Head of Novartis Pharma, David Epstein, said the approval "provides new hope for those debilitated by this excruciating condition". He added that "our vision is to realise the potential of Ilaris wherever interleukin-1 beta plays a key role".
Ilaris is already approved in more than 60 countries, including the USA, Japan and the EU for the rare diseases that form cryopyrin-associated periodic syndrome (CAPS). It is also being investigated in a number of rare inflammatory conditions, which include systemic juvenile idiopathic arthritis, tumour necrosis factor receptor-associated periodic syndrome and colchicine-resistant familial Mediterranean fever, as well as cardiovascular disease.
However, gout is potentially the most lucrative market though the path to approval in the USA has been a rocky one. The Food and Drug Administration issued a complete response letter on Ilaris in August 2011 and demanded additional clinical data. Novartis says it is working with the agency to determine the next steps for the drug in gouty arthritis.