Italy, May 12TH 2021 – Corion Biotech S.r.l. is pleased to announce that it has been granted the European Medicines Agency (EMA) Orphan Drug Designation for Preeclampsia.
This is a pivotal milestone for the development of our placenta-derived “Cell Therapy Without Cells” for the treatment of Preeclampsia, leading cause of fetal-maternal mortality worldwide.
The Orphan Drug Designation is awarded to drugs intended for the treatment of rare diseases for which no approved or resolving therapies are available. Patients with rare diseases cannot be excluded from the progresses of science and therapy since they share the same rights as all other patients. ODD protects these “orphan” diseases by stimulating research and development of new drugs through important incentives for the industries, health care and biotech.
Main incentives offered by EMA in the EU for Orphan designated drugs are:
- Protocol assistance by EMA;
- Access to the centralised authorisation procedure;
- Ten years of market exclusivity;
- Fee reductions for regulatory activities;