In March 2019, an experimental drug designed to treat Alzheimer’s disease named aducanumab failed a futility test during the process for approval from the Food and Drug Administration. Facing seemingly little hope for success, aducanumab’s producers Biogen and Eisai strongly considered abandoning the project.
However, when the drugmakers conducted further analysis on a larger dataset, they found that aducanumab reversed Alzheimer’s symptoms in some patients. Other Alzheimer’s treatments can only (at best) delay symptoms.
After their discovery, Biogen and Eisai requested the FDA to allow aducanumab to continue in the approval process. Although the drugmakers’ method for demonstrating aducanumab’s effectiveness is unconventional, and was heavily scrutinized, the federal agency allowed the resumption of clinical testing. A year later, aducanumab received priority review authorization, making it eligible to advance through the approval process more quickly.
Many expected the drug to receive full approval by March 2021. Sadly, the pathbreaking treatment’s approval faces additional obstacles after an FDA panel voted not approve the drug. Citing “data inconsistencies,” the panel recommended additional efficacy testing, which will lengthen the approval process. Despite initially expediting aducanumab’s approval, the agency is now unlikely to decide until June at the earliest.
This three-month delay comes at a considerable cost to patients suffering from Alzeheimer’s. Every 65 seconds, someone in the United States develops this debilitating disease. With no known cure, Alzheimer’s causes an estimated 500,000 deaths per year. About 125,000 citizens will die from the disease during the three-month delay the FDA deferred making a decision on whether to approve aducanumab.
Before Covid-19, many medical researchers argued that Alzheimer’s disease was the next pandemic. Unless treatment and detection improve quickly, it still might be.
So, what can be done for the millions of Alzheimer’s patients waiting for the FDA to make its decision? One option is for the agency to issue Emergency Use Authorization for aducanumab.
EUAs allow drug producers and physicians to distribute unapproved treatments during public health emergencies. During the Covid-19 pandemic, EUA have been used extensively to provide treatment, testing, and vaccines to patients.
Given the alarming prevalence of Alzheimer’s disease and considerable absence of new treatments, why not grant patients the opportunity to prolong their lives like we have during the pandemic?
Although Alzeheimer’s and COVID-19 are vastly different diseases, the story of how remdesivir became the first FDA-approved drug to battle the latter is remarkably similar to the current aducanumab controversy.
Developed in 2014, remdesivir’s producer Gilead Sciences entered the drug into a randomized control experiment to help treat Ebola virus complications. Although remdesivir performed well during its pre-clinicals, it failed to meet efficacy standards set by the FDA. Fearing the drug would not be approved, Gilead Sciences removed it from the trial.
Two years later, clinical trials performed at the University of Alabama at Birmingham, Vanderbilt University, and the University of North Carolina found remdesivir provide successful treatment for SARS and MERS patients (both are caused by viruses are similar to the one causing Covid-19). But the FDA prevented remdesivir from advancing in the approval process because those conducting the clinical trials could not enlist enough patients the agency deemed necessary to complete the studies.
When Covid-19 spread to the United States in late January 2020, healthcare providers began requesting remdesivir as a last-resort treatment. It was just what the doctor ordered. The twice-rejected drug helped patients recover faster and stave off pneumonia and respiratory infections in severe Covid-19 cases.
By May 2020, as Covid-19 cases and deaths expanded rapidly across the country, the FDA granted remdesivir an EUA to treat severe cases. Shortly afterward, the U.S. government purchased nearly 500,000 doses (at the time, all of the world’s supply) of remdesivir to distribute across the country.
By November 2020, the FDA had fully approved remdesivir to treat Covid-19 despite the drug never having formally begun the agency’s approval process. Regardless of its unconventional start and unprecedented approval, remdesivir has saved countless lives and played a prominent role in battling the virus.
Aducanumab could provide similar relief for patients suffering from Alzheimer’s disease as remdesivir has provided for Covid-19. Why wait?