FDAnews Drug Daily Bulletin

FAST-TRACK DESIGNATION GRANTED TO REGENERON'S ANTI-INFLAMMATORY TREATMENT

June 8, 2006
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The FDA has granted fast-track designation to Regeneron's chronic inflammation treatment, IL-1 Trap. The drug is a compound designed to attach to and neutralize a protein that causes inflammation when produced in excess.

IL-1 Trap is currently in late-stage clinical trials to test the drug's efficacy in patients with CIAS1-associated periodic syndromes -- a group of rare genetic disorders resulting in chronic inflammation. Data from the trial will be available by the end of the year, said the company.

Fast-track status is granted to new drugs that treat serious diseases for which there is an unmet medical need. The designation means the FDA will likely complete review of the therapy within six months.