FDA Approves Regeneron's Acralyst

The US FDA has approved Arcalyst (rilonacept, an interleukin-1 blocker) for the long-term treatment of two cryopyrin-associated periodic syndrome (CAPS) disorders: familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). Arcalyst, manufactured by Regeneron Pharmaceuticals, Inc. (Tarrytown, NY), is the first treatment for rare inflammatory syndromes.

Arcalyst blocks interleukin-1, which is a signaling protein secreted by certain immune-related cells in the body. Interleukin-1 acts as a messenger to regulate inflammatory responses, but in excess it can be harmful and has been shown to be key in the inflammation seen in CAPS sufferers with FCAS or MWS.

The FDA issued its approval following a priority review, which speeds the review process for patients who have unmet medical needs. Regeneron expects to launch Arcalyst within the next 30 days.