The designation covers all 25 countries that comprise the European Union. Similar orphan drug status was previously granted to Xechem by the FDA.
“Obtaining Orphan Drug status for our sickle cell disease product in both the European Union and the US brings to Xechem substantial advantages and incentives which will help facilitate approval of the drug and make it easier for us to bring this important medicine to market,” said Dr Ramesh Pandey, Xechem’s chairman & CEO.
In addition to granting the license holder protection from direct or generic competition for a period of ten years within the EU following drug approval, orphan drug status allows for regulatory assistance, reduced regulatory fees associated with applying for marketing approval, protocol assistance and scientific advice.