Novartis ($NVS) has grabbed one of two new indications it was shooting for with its rare disease drug Ilaris, one step toward turning the drug into a blockbuster.
The FDA approved Ilaris for treatment of SJIA, making it the only treatment for that condition that can be given as a monthly subcutaneous injection, Novartis said. "In the US, this approval marks the second Ilaris indication for patients living with rare, autoinflammatory conditions," said Timothy Wright, MD, global head of development for Novartis Pharmaceuticals. "We are committed to studying Ilaris in other IL-1 beta mediated inflammatory diseases, including several rare diseases for which treatment options do not currently exist."
The drug already is approved in the U.S. for cryoprin-associated periodic syndrome, a genetic disorder that causes the body to overproduce interleukin-1 beta, an inflammatory protein. Only about 7,000 people worldwide have this condition.
The company has hoped to get it approved in the U.S. for both juvenile arthritis and for gout, which is also triggered by overproduction of interleukin-1 beta. Novartis received approval in Europe in March for the drug to be used for gout, the most lucrative market for the drug. However, in the U.S. the FDA issued a complete response letter in 2011 asking for additional data for that indication.
- here's the release