Dyax Corp. Announces Marketing Authorization Application for DX-88 (ecallantide) Validated by European Medicines Evaluation Agency
Published: Jul 06, 2010
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ: DYAX) announced today that the European Medicines Agency (EMA) has completed its validation process for the Marketing Authorization Application (MAA) for potential approval to market DX-88 (ecallantide) in the European Union (EU). The completion of this validation process signifies that the formal scientific review of the MAA has begun. DX-88 (ecallantide) has been approved by the U.S. Food and Drug Administration (FDA) and is marketed as KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.