CSL Behring Receives EU Orphan Drug Designations for rVIIa-FP for Hemophilia A and B Treatment
Under these designations European Medicines Agency (EMA) will also provide CSL Behring with development assistance and with reductions in certain regulatory fees.
"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.
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