The drug is deigned to improve chronic inflammation in patients with CIAS1-Associated Periodic Syndromes (CAPS), a spectrum of rare genetic disorders.
Fast track designation are designed to aid the development and potentially accelerate the review of new therapeutic medicines intended to treat serious conditions for which there is an unmet medical need.
The fast track status allows Regeneron to submit clinical trial data to the FDA as it becomes available, and receive feedback, rather than having to wait to submit all data at once.
“The fast track designation is an important step in the regulatory process for the IL-1 Trap, as we come closer to completing the pivotal study,” said Dr George Yancopoulos, Regeneron’s executive vice president. “With no medical treatments approved to treat the chronic inflammation generated in people with these rare conditions, we hope the IL-1 Trap will provide a new option for these patients in the future.”
In April of this year, Regeneron announced the completion of enrollment in the pivotal study. The company expects top-line efficacy data from this trial by the end of 2006. Previously Regeneron received orphan drug designation for the IL-1 Trap in CAPS. This status is given to pharmaceuticals that treat diseases affecting less than 200,000 people in the US.