Epidemiology Studies on Spinal Cord Injury
A global pharmaceutical company with a new medicinal product for the treatment of acute spinal cord injury was seeking orphan designation for the product in the EU and the US. Orphan designation can be approved only if the pharmaceutical manufacturer demonstrates, using authoritative sources, specified prevalence of the condition in question.
To support our client's applications, an Analysis Group team including Managing Principal Mei Sheng Duh reported on the incidence and prevalence of acute spinal cord injury in both the EU and US, and conducted systematic literature reviews on the epidemiology of spinal cord injury in both countries. Sparse estimates for some EU countries and for some areas of the US, particularly regarding spinal cord injuries of an acute nature, presented challenges. We supplemented published estimates of incidence and prevalence with current state population estimates, as well as additional analyses of acute versus all spinal cord injuries, to demonstrate that the prevalence of acute spinal cord injury is rare both in the EU member states and in the US. The manufacturer included our epidemiological reports in its applications for orphan drug status.