CNS 'Graveyard Of Drug Development' Needs Oncology-Like FDA Regulatory Approach

Lundbeck executive calls for adaptive trial designs, transdiagnostic approach, and more scientific discussions between sponsors and the US Food and Drug Administration.

3D illustration male nervous system, medical concept. - Illustration — FDA gets advice on how to promote development of drugs for CNS disorders

How can the US Food and Drug Administration promote development of drugs in the central nervous system space? Katrin Rupalla, senior VP, head of regulatory affairs, medical documentation and R&D quality at Lundbeck Inc., believes the agency should apply an approach similar to that used in oncology for products being developed for dementia and cognitive impairment.

Rupalla spoke at a meeting FDA convened for stakeholders to provide review staff in the Center for Drug Evaluation and...