Biogen and Japan's Eisai reported that the FDA approved an expedited review for the marketing application for their new experimental treatment for Alzheimer's disease. Biogen stock experienced a gigantic surge after the announcement.
Which drug application got approved?
Biogen's new Alzheimer's drug, aducanumab, is being called a "potential blockbuster" new treatment for the disease, according to CNBC. The drug is specifically designed to delay the progression of Alzheimer's. The disease is fatal and the most common cause of dementia.
Alzheimer's is the sixth-leading cause of death in the United States. The CDC reported that the disease is "expected to affect 13.9 million Americans or 3.3 percent of the country's population by 2060."
It has been 17 years since the FDA reviewed an application for a new Alzheimer's treatment, according to Investor's Business Daily. Other drugs have been tested but they failed the trials.
The FDA will likely make a decision on the application for Biogen's new drug, aducanumab, by March 7, 2021, "but intends to act early on it if possible." The review could be a huge step forward in establishing an effective drug treatment for an extremely devastating disease.
"The FDA's acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer's disease," said Michel Vounatsos, Biogen's chief executive, in a news release. He also said that the new drug signals the "beginning of a new era of potential treatments for Alzheimer's disease."
How did Biogen stock react?
The news about the expedited review of Biogen's application led to a surge in Biogen stock. CNBC reported that Biogen shares were up 10 percent at $306 before the opening bell today.
In March 2019, Biogen was not as hopeful about aducanumab. The company scrapped two studies because it thought the treatment would likely fail. At the time, Biogen stock took a hit. In October 2019, the company reported that the drug was successful in one study. Biogen decided to continue developing the drug.
When the FDA application was approved, Biogen stock surged by double digits early today before the bell. According to Investor's Business Daily, "The relative strength line for Biogen stock has been rising sharply since the end of July. However, this comes after a period of steep decline that began mid-May."
What does the drug actually do?
Aducanumab has the potential to "impact underlying disease pathophysiology" and slow down the decline of cognitive and functional abilities in individuals who have been diagnosed with Alzheimer's.
Alzheimer's patients lose the ability to perform daily functions and live on their own over time. The drug could slow the progression of the disease and allow people to retain these all-important functions for a much longer period.
There are a few Alzheimer's drugs that are already approved and on the market. However, the drugs only treat the symptoms of the disease. They don't actually slow the progression of the disease. If aducanumab can slow the progression of Alzheimer's, it could be an incredible step toward treating this brutal disease.