Epidemiology Studies on Spinal Cord Injury
A global pharmaceutical company with a new medicinal product for the treatment of acute spinal cord injury is seeking orphan designation for the product in the EU and the U.S. 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 U.S. 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 U.S., particularly regarding spinal cord injuries of an acute nature, presented challenges. We supplemented published estimates of incidence and prevalence with current state population estimates, and 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 United States. The manufacturer has included our epidemiological reports in its applications and is awaiting approval for orphan drug status.
Associated Experts & Staff