The Substantial Costs Affiliated With Alzheimer Drug Development: Jeffrey Cummings, MD, ScD

With the exemption of the recent accelerated approval of aducanumab (Aduhelm; Biogen), there have been only 5 novel drugs since 1995 treat patients with Alzheimer disease (AD) that have reached FDA approval. To better understand the costs of AD drug development in the private sector, lead author Jeffrey Cummings, MD, ScD, and colleagues collected data on 1099 nonanimal AD clinical trials from the last quarter century.

At the end of the analysis, cumulative expenditures on the research and development stage were estimated at $42.5 billion, with the greatest costs ($24,064 million; 57%) incurred during phase 3. Moreover, the study mainly highlighted the large number of failures within the space, including most notably in the later stages. Of the 235 agents analyzed, 112 remain in active clinical development, 6 have reached commercialization, and 117 have had negative outcomes in various stages of clinical development—equating to a 95% failure rate.

Cummings, MD, ScD, professor of brain science, and director, Chambers-Grundy Center for Transformative Neuroscience, University of Nevada–Las Vegas, sat down with NeurologyLive®to discuss the reasoning behind his analysis and the most notable takeaways from the data. He also briefly mentioned the staggering number of patients that have been in these trials and the role they play in drug development.