– Al Sandrock, M.D., PhD, Head of Research and Development, Biogen
Developing effective therapeutics for Alzheimer’s disease has been challenging for the biopharmaceutical industry. In this video, Dr. Jeffrey Cummings—one of the world’s preeminent experts in Alzheimer’s disease research—reviews the investment and innovation history in Alzheimer’s disease across the industry.
Despite the tens of billions of dollars that have been spent on pharmaceutical research and development in Alzheimer’s disease—and the contributions of the over 175,000 individuals who have participated in clinical trials since 1995—there have been over 110 discontinued clinical development programs in the past 25 years and the U.S. Food and Drug Administration (FDA) has yet to approve any products that modify the course of Alzheimer’s disease progression.
This investment and community participation has contributed to the approvals of five novel Alzheimer’s therapies to date, and although these approved treatments do not impact the underlying progression of the disease, they can help improve symptoms.
In 1993 the FDA approval of the first treatment for the symptoms of Alzheimer’s disease led to rapid innovation and was followed soon after by others. Unfortunately, this trend ended in 2003 and it has now been more than 17 years since a novel treatment for Alzheimer’s disease was approved.
Meanwhile, the unmet need in Alzheimer’s disease remains extremely high, for individuals with the disease as well as their caregivers and society at large. One in nine Americans over the age of 65 have been diagnosed with Alzheimer's, and this prevalence is expected to continue to rise as the population ages over the coming decades. The financial burden of Alzheimer’s is staggering as well, with an estimated $612 billion per year spent on care in the U.S. These costs—which will also continue to rise—are borne largely by patients and their caregivers, who are disproportionately likely to be minorities, veterans, and women.
Despite the challenges and history of failures in Alzheimer’s clinical development, an incredible wealth of knowledge has been acquired over the past three decades, and we believe this knowledge will provide a strong foundation for future success. Thanks to the contributions of the patients and caregivers who participate in clinical trials and the rich history of investment in innovation summarized in this video, there remains hope for a future in which new treatments may be available to help address the underlying causes of Alzheimer’s disease and mitigate its inordinate burden.
I invite you to watch Dr. Cummings review this history and explore what approval of novel therapies could mean for patients, their caregivers, and society at large.