Aducanumab tens of billions of sales potential-the first Alzheimer's disease drug approved in 18 years

On June 7, 2021, the U.
S.
Food and Drug Administration (FDA) accelerated the approval of Biogen's aducanumab for the treatment of Alzheimer's disease
.

Aduhelm represents the first treatment approved for AD.
This is the first new treatment approved for Alzheimer’s disease since 2003.
It is also the first treatment aimed at the basic pathophysiology of the disease.
Sold under the trade name Aduhelm
.

Alzheimer's disease (AD) is a progressive degenerative disease of the central nervous system characterized by cognitive dysfunction and behavioral impairment
.

Clinically, it is characterized by comprehensive dementia such as memory impairment, aphasia, impaired spatial function, and personality and behavior changes
.

It is now widely believed that the symptoms of Alzheimer's disease are caused by the loss and death of connections between brain cells, but it is not yet fully understood what causes these cell deaths
.

In the field of AD drug development, the "amyloid hypothesis" can be said to be one of the most studied pathogenesis theories, but there is still a lack of evidence for the multi-dimensional association between Aβ plaques and AD outcomes
.

For many years, various pharmaceutical companies have begun to invest in the research and development of AD drugs, but many have failed.
For details, please refer to this article: From Bapineuzumab to Donanemab, why is the development of anti-Aβ antibodies so foggy? The author has combed the history of AD drugs based on the amyloid hypothesis in detail for us
.

Biogen and its partner Eisai abandoned the drug plan in March 2019, after an ineffective analysis stated that the drug would not reach its endpoint
.

Then, just a few months later, Biogen and Eisai published trial reports after a comprehensive analysis and a dialogue with the FDA.
One of the trials, the Phase III EMERGE study, reached the primary endpoint at the highest dose, indicating a significant reduction in clinical decline
.

The data was released in December of that year and submitted to the FDA for application in March 2021
.

The FDA requested more information as a major amendment and formally approved it on June 7
.

Biogen's stock price was suspended on Monday morning awaiting the FDA's decision.
Once trading resumes, the stock price rose by approximately 52% to approximately US$434 per share
.

Biogen sets the price of Aduhelm at US$4312 per session (for patients with average weight), which means that it costs US$56,000 per year
.

This far exceeds the annual cost of 8,300 US dollars estimated by previous experts
.

Its high expenses may put some pressure on patients and doctors
.

But at the same time, some analysts estimate that Biogen may achieve peak sales of 10 billion yuan by virtue of this approval
.

Reference: https:// com/article/biogen-s-big-day-fda-to-decide-on-alzheimer-s-drug-s-fate/