Novartis announced that the FDA has approved Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged >2 years. Ilaris is the first interleukin-1 beta inhibitor approved for SJIA and the only treatment given as a once-monthly SC injection. Ilaris works by neutralizing interluekin-1 beta for a sustained period of time, therefore inhibiting inflammation.
The approval was based on two Phase 3 trials in patients with SJIA aged 2–19. Study 1 (N=84) showed that 84% of patients treated with one dose of Ilaris achieved the primary endpoint of the adapted pediatric ACR30, compared to 10% achievement of ACR30 for placebo at Day 15. In Study 2 (N=177), 62% of patients that attempted corticosteroid tapering (n=92) were able to substantially reduce their use, and 46% completely discontinued corticosteroids.
Ilaris is already indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children ≥4 years of age including: Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).
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