May 10, 2013 | By Márcio Barra
Back in March 2013, Novartis saw their rare disease drug Ilaris receiving positive opinion from the CHMP and the European Commission for the treatment of patients with frequent attacks of acute gouty arthritis. Today, Ilaris received approval for yet another rare indication, this time from the FDA, for the treatment Systemic juvenile idiopathic arthritis, the most common form of arthritis in children and adolescents. FDA’s approval makes Ilaris the only treatment for juvenile idiopathic arthritis that can be given as a monthly subcutaneous injection. The approval was based on two Phase III trials in SJIA patients, aged 2–19.
Ilaris, or canakinumab, was approved back in 2009 by the FDA and EMA for the treatment of cryopyrin-associated periodic syndromes, or CAPS, a suite of rare (7,000 people worldwide), life-long, genetic autoinflammatory diseases including familial cold autoinflammatory syndrome, Muckle–Wells syndrome and others. Ilaris is a biologic. More specifically a selective, fully human, monoclonal antibody that inhibits IL-1 beta, a part of the body’s immune system defenses that, when over expressed, leads to inflammation.
Novartis strategy of betting for new indications for its orphan drugs is definitely paying off, and if Ilaris keeps this positive momentum going, blockbuster status is inbound.