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Q & A: Biogen to ask FDA to Approve Early Alzheimer's Disease Treatment

Q & A: Biogen to ask FDA to Approve Early Alzheimer's Disease Treatment
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October 23, 2019
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Biogen Inc. announced it will seek U.S. Food and Drug Administration (FDA) approval for the experimental drug aducanumab after study results showed it reduced clinical decline in people living with early Alzheimer's. On behalf of the more than 5 million Americans living with Alzheimer's and their family members, the Alzheimer’s Association is encouraged that Biogen will pursue regulatory approval for aducanumab.

Q:  How do I get aducanumab? When will it be available?
A:  At this point, the drug is not available to the public. It is an investigational drug and is available only through clinical trials. Biogen plans to offer access to aducanumab only to eligible individuals who were previously enrolled in the Phase 3 studies, the long-term extension study for the Phase 1b PRIME study, and the EVOLVE safety study.
The company plans to submit an application with the FDA in early 2020. The FDA will then consider the application and review the data to evaluate whether the benefits of the drug outweigh the risks.

Q: Will this drug actually slow down Alzheimer’s disease? If so, by how much?
A: These studies seem to show that aducanumab can reduce the rate of decline in people with early Alzheimer’s disease. In addition, aducanumab significantly reduced brain amyloid levels, and its effectiveness improved as the dose was raised. As far as we know, it is not a cure.
The company states that, compared to placebo, greater exposure to high dose aducanumab resulted in significant benefits on measures of cognition and function such as memory, orientation and language, as well as activities of daily living. In addition, aducanumab significantly reduced brain amyloid levels, with the most benefit at the highest dose of drug administered.

Q:  Will aducanumab work on everyone or just certain people?
A:  As with all medications, some individuals will be able to tolerate it better than others, and it will have different effects based on the person’s overall health and disease state.
The study results shared today showed that the drug slowed decline in people with mild dementia due to Alzheimer’s and mild cognitive impairment due to Alzheimer’s. It is not known how the drug may affect people who are in moderate to severe stages of dementia, or people who have the brain changes associated with Alzheimer’s disease but who do not yet have symptoms. Given the mechanism of the drug, it is highly unlikely that the drug would benefit people whose MCI or dementia is caused by something other than Alzheimer’s disease. 
 
Q: Is aducanumab safe?
A:   The safety and efficacy of aducanumab were being evaluated in the ENGAGE and EMERGE clinical trials. There were some adverse effects from the therapy, including headache and excess accumulation of fluid in the brain (known as ARIA-e). The company reported that those issues resolved in a few weeks without long-term consequences. The FDA will consider the safety results when it reviews the full data in the application next year.

Q:  Why is it just for early stage people? Have they tested it on people in middle or late stage?
A:  At this point, the clinical studies have only enrolled and tested the therapy on persons with mild dementia and mild cognitive impairment (MCI) due to Alzheimer’s disease. The therapy has not yet been tested on people with more advanced cases of dementia.

Q:  Why does it take so long to reach the market?
A:  The FDA will need to evaluate the data to make sure the drug is safe, efficacious and does not have long-term side effects that may cause more harm than benefit. The FDA may also require the company to do additional clinical trials in a larger or more diverse population before it can consider the treatment for market approval. While we are all eager for an approved treatment for Alzheimer’s disease, we must make sure the therapy is safe and does what the company claims it can do to help individuals living with dementia.

Q:   How do I get (or get my family member) in the study?
A:  Biogen is planning to offer aducanumab to eligible patients previously enrolled in clinical studies. They are not recruiting for new study participants at this point.

Q:  Can I get this drug through “Compassionate Use” or “Right to Try”?
A:  People who have those questions should contact the company directly. Here’s a link to their website about the aducanumab announcement with contact information for the company.  https://biogenalzheimers.com/

Q: Is this the cure for Alzheimer’s? Does this drug prevent Alzheimer’s? 
A: Study participants included people with mild Alzheimer’s dementia and mild cognitive impairment due to Alzheimer’s. Benefits were slowing of cognitive and functional decline, compared to people who took a placebo. People still declined, but at a significantly slower pace. They were able to do better at functioning independently on everyday tasks for a longer period of time, but they were still losing memory and function. It is not yet known whether the drug may prevent or delay the onset of Alzheimer’s, since everyone in the study already have cognitive impairment due to Alzheimer’s.
   
Q: How much better did the participants get? In what areas? 
A: According to the company, study participants who received aducanumab at the highest dose experienced significant benefits on measures of cognition and function, such as memory, orientation, and language. Patients also experienced benefits on activities of daily living, including conducting personal finances, performing household chores such as cleaning, shopping, and doing laundry, and independently traveling out of the home.
 
In addition, aducanumab significantly reduced brain amyloid levels, with the most benefit at the highest dose of drug administered.
 
Q: How is the drug administered? 
A: The drug is administered by an infusion into the bloodstream. In the clinical trials, it was administered to the participants in the study once a month to achieve consistent levels of either low or high doses of the drug.
 
Q: What will the drug cost? Will it be covered by my insurance? 
A:  There is no available information on how much the drug will cost because the FDA has not reviewed or approved it for use at this time.
 
If it is scientifically proven to be an effective treatment and gains FDA approval, the Alzheimer’s Association will advocate for its coverage by Medicare and will continue to advance policies that improve the outcomes for all those affected by Alzheimer’s. 
 

Alzheimer's Association

The Alzheimer's Association is the world's leading voluntary health organization in Alzheimer care, support and research. Our mission is to eliminate Alzheimer's disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimer's. For more information, visit www.alz.org.

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