News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Dyax Corp. (DYAX) Announces Marketing Authorization Application for DX-88 (ecallantide) Validated by European Medicines Evaluation Agency


7/6/2010 10:17:41 AM

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.

Read at BioSpace.com

comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES