Turin, May 12th 2021 – Corion Biotech is pleased to announce that it has been granted the European Medicines Agency (EMA) Orphan Drug Designation (ODD) for CB-ChMF-11 in the treatment of Preeclampsia.
This is a pivotal milestone for the development of our placenta-derived product for the treatment of Preeclampsia, leading cause of fetal-maternal mortality worldwide. This condition was estimated to be affecting approximately 4 in 10,000 persons in the EU, at the time the application was made.
The ODD is awarded to drugs intended for the treatment of rare diseases for which no approved or resolving therapies are available. ODD protects these “orphan” diseases by stimulating research and development of new drugs through important incentives for the industries, health care and biotech, such as protocol assistance by EMA, access to the centralised authorisation procedure, ten years of market exclusivity and fee reductions for regulatory activities.