The European Medicines Agency EMA’s Committee for Orphan Drugs in Europe (Committee for Orphan Medicinal Products, COMP) has notified A1M Pharma that they have taken a positive decision regarding A1M Pharma’s application for Orphan Drug Designation in Europe. This means that COMP has determined that the application meets all the criteria and recommends that the European Commission should grant a formal Orphan Drug Designation. The European Commission will shortly issue a formal decision on Orphan Drug Designation for A1M Pharma’s treatment for preeclampsia.
Orphan drug status
In short, obtaining Orphan Drug Designation means that the product receives market exclusivity after market approval even if the patents are no longer valid. Orphan Drug Designation provides exclusivity in the EU for ten years following the date on which A1M Pharma receives authorization. In addition, A1M Pharma will receive free consultation for scientific advice and lower costs for regulatory pre-commercialization applications.
CEO Tomas Eriksson comments
We have known for a long time that preeclampsia is a prospective area for Orphan Drug Designation, which means briefly that the illness is of a very serious nature and that the need to develop drugs in the area is pressing. Obtaining Orphan Drug Designation is very pleasing to A1M Pharma and will be of huge importance in future discussions with our development partners. The recommendation from COMP will now be forwarded to the European Commission to issue a formal decision on Orphan Drug Designation for A1M Pharma’s treatment for preeclampsia .
For further information, please contact
Tomas Eriksson, CEO, A1M Pharma AB
Phone: 046-286 50 30