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Biogen Soars 58% After FDA Approval for Alzheimer's Treatment

Stock MarketsJun 07, 2021 11:07AM ET
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© Reuters.

By Christiana Sciaudone

Investing.com -- Biogen (NASDAQ:BIIB) received federal approval for its controversial Alzheimer's drug. Shares jumped 58% in midday trading after being halted for the news.

The U.S. Food and Drug Administration approved the drug Monday, the first Alzheimer's treatment approved in 18 years. 

Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.  The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia, the FDA said in a statement.

It's been a bumpy ride for the drug, with the FDA first saying it appeared to be effective, followed by an outside panel of agency advisers saying more data was needed, Bloomberg reported. The agency said today it concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.

Although the Aduhelm data are complicated with respect to its clinical benefits, the FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients. As a result of FDA’s approval of Aduhelm, patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease, the agency said.

Alzheimer’s is the U.S.'s sixth leading cause of death. On average, a person with Alzheimer’s disease lives four to eight years after diagnosis, but some patients can live up to 20 years with the disease.  More than 6 million Americans are living with Alzheimer’s disease and this number is expected to grow as the population ages. 

Patient advocacy groups and some doctors rallied for the drug's approval, but some experts said there's a lack of compelling evidence that aducanumab can provide meaningful benefit, Reuters said.   

Biogen has estimated that around 1.5 million Americans would be eligible for treatment with aducanumab, and could result in billions in revenue for the company, likely at a cost to Medicare. 

The Institute for Clinical and Economic Review, a drug pricing research group, said in May there's "insufficient" evidence that aducanumab provides a net health benefit. Any drug proven to halt progression of Alzheimer’s-related dementia could be fairly priced at $50,000 to $70,000 per year, Reuters reported.

The FDA said it will continue to monitor Aduhelm as it reaches the market and is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. "If the drug does not work as intended, we can take steps to remove it from the market," the FDA said.



Biogen Soars 58% After FDA Approval for Alzheimer's Treatment
 

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Comments (3)
Robert Cutler
Robert Cutler Jun 07, 2021 1:23PM ET
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thank you D Jones
Paul Freeman
Paul Freeman Jun 07, 2021 12:12PM ET
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50k to 70k a year for something that isn't even proven to help. Robbery.
Klaus Weyers
Klaus Weyers Jun 07, 2021 12:12PM ET
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if you cant afford a Mercedes, buy a Ford.. but let those who want the drug pay for it.. in time price will come down huge.. that is how free markets and cspitalism works.. dont mess with it..
Tony Huynh
Tony Huynh Jun 07, 2021 12:12PM ET
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klaus, oh then why is Insulin price still skyhigh even after years in the market. Also can you explained why only drugs in US cost double to triple compare to other countries?
Dave Jones
Dave Jones Jun 07, 2021 12:08PM ET
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probably too late to help joe
 
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