Can regulators have a role in facilitating the development of new medicines for Parkinson's disease?

Parkinson's disease (PD) is the second most frequent neurodegenerative disorder, and its prevalence has doubled in the past 25 years. New formulations of levodopa have recently been marketed that improved the ability to treat PD, but in the European Union, no new active substance for PD has been marketed since 2015, whilst two new agents have been marketed elsewhere. In spite of being the most treatable neurodegenerative disorder, several unmet medical needs still exists in PD, and efforts both from researchers, drug developers and regulators are needed to facilitate further developments in the field. There are several reasons that may account for the lack of new treatments for PD. Regulatory agencies provide scientific advice and have developed several programs to foster drug development. This manuscript discusses the main obstacles identified in the development process, the present status of approvals in European Union and the United States, and the presently available mechanisms to optimize drug development and marketing.