The FDA has approved Ilaris (canakinumab, from Novartis), a fully human monoclonal antibody that selectively blocks interleukin-1 beta (IL-1 beta), for the treatment of patients ≥4 years of age with cryopyrin-associated periodic syndrome (CAPS), including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). This approval was based results from a Phase 3, three-part, one-year study involving 35 patients 9–74 years of age with varying degrees of disease severity. Part 2 of the study included the primary endpoint, a comparison between the number of patients treated every two months with Ilaris who experienced disease outbreaks compared to those on placebo. Results showed that none of the 15 patients treated with Ilaris experienced an outbreak compared to 13 out of 16 patients treated with placebo (0% versus 81%, respectively). Study results published in The New England Journal of Medicine showed that Ilaris produced a rapid, complete, and sustained response in the majority of patients.
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