After the experimental treatment for Alzheimer’s named aducanumab failed a futility test, its producers Biogen and Eisai lost hope the Food and Drug Administration would ever approve it. Despite promising clinical results through the approval process, the producers abandoned their project in 2019.
Eight months later, Biogen developed an expanded dataset to reassess aducanumab’s impact on patients taking larger doses. To the producer’s amazement, the data indicated that some patients receiving treatment were able to reverse the symptoms of Alzheimer’s disease.
Reinvigorated, Biogen and Eisai requested that the FDA allow aducanumab to re-enter the approval process. Their request challenged the status quo on several margins. At the time, the FDA did not allow drugs to resume the approval process after exiting. It also did not consider the findings provided within the expanded dataset to be permissible to approve drugs.
Despite widespread criticism, the FDA allowed aducanumab to resume the approval process. The agency later granted aducanumab priority review in August 2020, where it received specialized attention and a faster route to approval.
But the already once abandoned drug continued to face obstacles. In early 2021, an FDA advisory panel recommended that the agency not approve the drug because of alleged “data inconsistencies.” Already in uncharted waters, the FDA announced it would reach decide whether to approve the drug or not in June.
They have made their decision.
The FDA approved aducanumab for the treatment of Alzheimer’s disease. The approval comes at a critical time for those suffering from the debilitating and increasingly common disease. According to the Fischer Center for Alzheimer’s Research Foundation, someone in the US develops Alzheimer’s every 65 seconds. In 2019, nearly 121,500 patients died from Alzheimer’s disease.
Increasingly common and deceptively deadly, the disease has also been tough to treat. As the FDA notes, the newest treatment for Alzheimer’s disease was approved in 2003.
Perhaps more remarkably, approving aducanumab provides an avenue for the FDA to incorporate additional forms of evidence into its approval process. With many drug producers already implementing big data and other analytics, if the agency decides to expand its scope of acceptable evidence, the variety of approved drugs could significantly expand and slash the time it takes drugs approved.
Others have realized the FDA may have set a precedent by approving aducanumab. Many continue to be critical of the FDA’s decision, declaring evidence that the drug works is weak and the choice is “dangerous.”
Like other Alzheimer’s treatments, aducanumab poses its own risk of failure and side effects. But given the rapid expansion and lack of treatment options for Alzheimer’s, this is a risk well worth taking for many.
Further, the FDA’s actions throughout the pandemic have clearly shown that less oversight and stringency over approval is just what the doctor ordered.
As I noted in my article published in the Southern Economic Journal, the drug remdesivir showed promising results in treating Ebola during the 2014 outbreak. However, the drug failed to meet efficacy standards, and its producer decided not to pursue FDA approval. Remdesivir later showed promise in treating SARS and MERS in 2016 in privately funded clinical trials. Unfortunately, it was again unable to advance toward FDA approval because it could not meet sample size standards determined by the agency.
In early 2020, as the virus spread across the country, the FDA granted patients and healthcare providers emergency use access to remdesivir (at their strong request) to treat Covid-19. It quickly became the standard of treatment for severe and mild cases of Covid-19. Clinical studies also found the drug also reduces the risk of developing pneumonia while infected and often helped hospitalized patients recover more quickly.
Despite its history, the FDA approved remdesivir for the treatment of Covid-19 in October 2020. The drug never underwent the full FDA approval process. Not even the FDA thought it needed to.
Similar breaks from protocol were used to develop Covid-19 vaccines quickly. Under Operation Warp Speed, the FDA allowed vaccine developers to stagger the approval process and advance in the approval process before each phase was completed.
After completing the expedited and significantly less demanding warp speed process, the FDA granted emergency use authorization to three Covid-19 vaccines in late 2020. Most recently, Pifzer and Moderna requested FDA approval for their Covid-19 vaccines. With over half the US population fully vaccinated, the request is mainly to allow the vaccines to remain on the market after the pandemic ends.
Rather than be skeptical of the FDA’s recent approval of aducanumab, we should remind ourselves of the recent FDA successes in reducing its regulatory oversight and stringency. Doing so has curtailed and helped address the Covid-19 pandemic. aducanumab’s could be the breakthrough needed to help the millions suffering from Alzheimer’s. Let’s hope this is the first of many.