Orphan drug status was granted to CSL’s Vlla drug for hemophilia. The designations will entitle CSL to exclusively market VIIa in Europe for 10 years, if the product at the stage of license application fulfils the orphan drug requirements.
"CSL Behring welcomes Orphan Drug Designation for rVIIa-FP as support of our ongoing commitment to developing, manufacturing and marketing products for the treatment of rare and serious diseases, such as hemophilia with inhibitors," said Val Romberg, Senior Vice President, Global Research & Development. "We will continue to work closely with the EMA to make this important therapy available to patients as soon as possible."
An orphan drug designation application has not yet been submitted in the United States.
To learn more about orphan drugs, check out World Orphan Drug Congress USA 2012.