CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ: DYAX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) and has designated the application for Priority Review. Based on this designation, the FDA Prescription Drug User Fee Act (PDUFA) target action date is March 23, 2009, or six months from the BLA submission date of September 23, 2008. Priority Review designation is intended for those products that address unmet medical needs. DX-88 has previously been granted Orphan Drug designation as well as Fast Track status by the FDA.
