Regeneron Pharmaceuticals, Inc. announced June 8th it completed rolling submission of a Biologics License Application (BLA) to the FDA and had asked for priority review of biologic Interleukin-1 (IL-1) Trap (rilonacept) for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).

CAPS is a spectrum of rare inherited inflammatory conditions, including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, with symptoms that include fever, chills, rash, fatigue, joint pain, and eye redness.

Estimates put the number of U.S. patients suffering from CAPS at somewhere between a few hundred and a few thousand. In clinical trials, patients gave themselves weekly subcutaneous injections of the IL-1 Trap.

“Currently, there are no medicines approved for patients suffering from CAPS, and we are hopeful that the IL-1 Trap will play an important role in the future treatment of this rare condition," said Dr. Leonard S. Schleifer, CEO of Regeneron.

The FDA previously granted Orphan Drug status and Fast Track designation to the IL-1 Trap for the treatment of CAPS, and if it grants priority review, the drug could be on the market by early 2008.