The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has recommended Orphan Drug Designation (ODD) for Erytech Pharma's investigational product Enhoxy.
The drug, which is used to treat sickle cell disease, increases the oxygenation properties of red blood cells by reducing their oxygen-hemoglobin affinity and allowing them to release more oxygen.
Enhoxy also targets to reduce the number of blood transfusions needed in the patients affected with the disease.
An ODD provides ten years of market exclusivity after marketing authorization in all member states of the European Union, a streamlined regulatory review process and important fee reductions.
Erytech Pharma Executive Vice President and Chief Scientific Officer Yann Godfrin said,"I am delighted with this positive opinion. This ODD is an important step for the development of the ENHOXY product that, we believe, can bring significant benefit to the patients suffering from this debilitating disease.''
