The orphan drugs status will allow the company to market its recombinant factor VIIa fused with albumin in Europe for a span of 10 years if the product at the stage of license application fulfils the orphan drug requirements.
Following the EC’s orphan drug status the European Medicines Agency (EMA) will offer development assistance and with reductions in certain regulatory fees to CSL Behring.
CSL Behring Global Research & Development senior vice president Val Romberg said the company welcomes orphan drug designation for rVIIa-FP as support of their ongoing commitment to developing, manufacturing and marketing products for the treatment of rare and serious diseases, such as hemophilia with inhibitors.
"We will continue to work closely with the EMA to make this important therapy available to patients as soon as possible," Romberg said.