Novartis' Ilaris gets new indication of childhood arthritis from US FDA

Swiss pharmaceutical major Novartis (NIVN: VX) said this morning (May 10) that the US Food and Drug Administration has approved its Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years and older.

Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection. In addition to its approval for SJIA in the USA, Ilaris is approved in the European Union for the treatment of refractory gouty arthritis, and in more than 60 countries, including in the EU, USA, Switzerland and Japan for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), a rare, lifelong, genetic disorder with debilitating symptoms.

The rarity of that condition means that sales have been relatively small, coming in at $72 million last year. Gouty arthritis is a much bigger market for the drug and, along with a juvenile arthritis indication, could push Ilaris towards blockbuster status with sales in excess of $1 billion a year.