Summary
Regeneron Pharmaceuticals, Inc. (REGN) announced via an 8-K filing dated November 1, 2007, that the U.S. Food and Drug Administration (FDA) has extended the action date for its priority review of the Biologics License Application (BLA) for rilonacept. Rilonacept, also known as the Interleukin-1 (IL-1) Trap, is being considered for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).
Key Highlights
- 1FDA has extended the action date for the priority review of rilonacept's BLA by three months.
- 2The new action date for the FDA's decision is February 29, 2008.
- 3Rilonacept is being developed for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).
- 4The filing incorporates by reference a press release dated November 1, 2007, detailing this information.
Frequently Asked Questions
This 8-K filing is primarily to inform investors about the FDA's decision to extend the review period for Regeneron's Biologics License Application (BLA) for rilonacept.
Rilonacept, also referred to as the Interleukin-1 (IL-1) Trap, is a drug candidate developed by Regeneron for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), a group of rare genetic inflammatory disorders.
The filing states the FDA extended the action date for the priority review. While specific reasons are not detailed in this 8-K, extensions often occur to allow the FDA more time to thoroughly review complex applications or to consider additional information.
The FDA's action date for its review of the rilonacept BLA has been extended to February 29, 2008.