The FDA is extending the review of the drug by three months to July 16, 2007. This is in order to provide time for review of an amendment made to the new drug application. The amendment was provided in response to an approvable letter from the FDA which stated the agency needed extra information for a final approval.
Kiacta has received orphan drug status in the US, the European Union and in Switzerland. Kiacta treats a progressive and fatal condition known as AA amyloidosis which occurs in a proportion of patients with chronic inflammatory disorders, chronic infections and inherited diseases. Currently, there is no approved therapy to treat AA amyloidosis and about half of all patients with the disease die within five years of diagnosis.