Novartis gets FDA ok for Ilaris
13.05.2013 - Swiss Novartis AG has gained authorisation from the FDA to market its IL-2beta blocker Ilaris in childhood arthritis.
The market approval of Novartis’ immune system blocker canakinumab comes only two weeks after the FDA has cleared Roche’s first-in-class IL-6 receptor blocker Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in children aged 2 years and older.
SJIA is a rare, debilitating form of arthritis in children that worsens over time and affects approximately 30 in 100,000 children. The approval of the Novartis once monthly subcutaneously administered human monoclonal antibody was based on two Phase III trials. The first one showed that 84% of patients treated achieved ACR30 versus 10% in the placebo arm at day 15. In an open-label part of the other study, 92 of 128 patients attempted corticosteroid tapering. 57 were able to reduce their use of corticosteroids, and 42 completely discontinued corticosteroids.
Roche had reported that 83% of patients that took its monthly intravenously administered IL 6 receptor antagonist tocilizumab as monotherapy achieved an ACR 30 response at week 16 compared to baseline. Additionally, Actemra-treated children experienced significantly fewer disease flares (26%) compared to placebo-treated patients (48%).