The world may be focused on COVID-19 this year, but the battle against Alzheimer’s disease continues with no effective treatments. Biogen Inc. (NASDAQ: BIIB) is one company that hopes to remedy that unfortunate situation. It has announced that the U.S. Food and Drug Administration (FDA) has granted a priority review status to its experimental Alzheimer’s drug after accepting the Biologics License Application (BLA) for its investigational human monoclonal antibody called aducanumab.
If approved by the FDA, this aducanumab drug would be the first therapeutic that has FDA authorization with a target of slowing the progress of Alzheimer’s disease. The investing community knows that any company that receives FDA approval for an Alzheimer’s treatment that is even remotely effective in prevention, delays or treating Alzheimer’s will reap untold billions of dollars in new revenues. This will be an instant “blockbuster” drug if approved.
Note that aducanumab initially failed a Phase 3 trial, but Biogen decided to move forward with the drug after subsequent analysis showed that the data was better than originally believed. Biogen’s release also noted that the company did not use its Priority Review voucher for the aducanumab BLA.
Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.
As for the societal and personal toll that Alzheimer’s brings, tens of millions of people worldwide live with the disease, according to World Health Organization. The Alzheimer’s Association indicates that 5 million Americans are currently living with the disease, but that number is expected to be nearly 14 million by 2050. The group also indicated that Alzheimer’s and other dementias will cost the United States $305 billion in 2020 alone.
Alzheimer’s disease is characterized by changes in the brain, including the abnormal accumulation of toxic amyloid beta plaque, which begins approximately 20 years before patients exhibit symptoms of the disease. Mild cognitive impairment due to Alzheimer’s disease is one of the earliest stages of the disease, when symptoms start to be more visible and can be detected and diagnosed. Current research efforts are focused on catching and treating patients as early as possible for the best chance of slowing or stopping the progression of Alzheimer’s disease.
Shares of Biogen moved higher in July after the company submitted its application to the FDA. That filing was later than initially been planned, although timing around FDA filings can vary greatly. Now that the FDA has accepted Biogen’s application and granted a priority review, the current belief is that this will speed up the approval process.
According to Biogen’s release, the FDA is now required to make a decision by March 7, 2021. It is possible because of the expedited review that the approval decision could be announced sooner.
The FDA also will hold an advisory committee meeting using outside experts to get input on the drug. Those dates have not yet been set. As with all advisory meetings, a formal FDA decision to approve or not approve a drug does not always coincide with the advice of those advisory committees.
Biogen’s release confirmed that aducanumab, if approved, would become the first therapy to reduce the clinical decline of Alzheimer’s disease. The company also noted that, if approved, it would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.
One challenging issue in the Alzheimer’s community is that many researchers do not even agree on what is the best way to target the disease. Biogen’s statements included:
We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer’s disease that will inspire even more discovery and innovation to bring hope to those affected by this devastating disease. … If aducanumab is approved, we expect that it will make a difference in the lives of people living with Alzheimer’s disease.
Until Friday’s big pop on the news, Biogen shares had traded slightly lower in 2020. The stock price was up 9.3% at $303.50 on Friday, in a 52-week range of $215.78 to $374.99. The Refinitiv consensus price target is $300.54.