FDA Accepts Icatibant NDA

German drugmaker Jerini’s new drug application (NDA) for Icatibant in the treatment of hereditary angioedema (HAE) has been accepted by the FDA and granted priority review. 

HAE is a genetic disease characterized by unpredictable recurring swelling attacks of the hands, feet, face, larynx and abdomen.

The agency has issued an action date of April 26, 2008, and scheduled a Pulmonary-Allergy Drugs Advisory Committee meeting for Feb. 20, 2008,  Jerini said.