FDA Says Ilaris OK for Childhood Arthritis

ILARIS (canakinumab) 180mg for Injection
ILARIS (canakinumab) 180mg for Injection

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).

For more information call (888) NOW-NOVA or visit the Novartis website.