Novartis has received FDA approval for Ilaris (canakinumab), for the treatment of cryopyrin-associated periodic syndrome (CAPS) in children and adults. The FDA granted priority review to Ilaris, based on its potential to meet an important clinical need for patients with CAPS.
Ilaris, previously known as ACZ885, is a fully human monoclonal antibody that rapidly and selectively blocks IL-1ß.
Ilaris is the first approved treatment for patients as young as four years old suffering from two forms of CAPS: familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), said the company.
The dosing schedule for Ilaris is once every eight weeks, which is less frequent than the current approved therapy. Also, more than 90% of patients studied did not experience any injection site reactions, and those that did occur, were of a mild-to-moderate nature.
Trevor Mundel, Head of Global Development, Novartis, said: We are excited about this first Ilaris approval which reflects our commitment to developing innovative treatments that address unmet medical needs, regardless of the size of the patient population.