New Unique Alzheimer's Drug Gets Accelerated FDA OK

Read Time: 3:39
Published: Jun 7th, 2021
Unique Alzheimer's Drug Gets Accelerated FDA OK

Over six million Americans now have Alzheimer's disease, the most common form of dementia. The number of people afflicted with this debilitating disease will increase substantially in the decades ahead as more people live longer and longer. Now, for the first time since 2003, the Federal Food and Drug Administration has approved a new medication for Alzheimer's disease.

The medication, Aduhelm, was approved using the accelerated approval pathway, which is used for drugs dealing with a serious or life-threatening illness that can provide meaningful therapeutic advantages over existing available treatments.

According to experts, the drug should generate billions of dollars in revenue for the manufacturer Biogen Inc. However, there is concern about how effective the medication is in improving symptoms of Alzheimer's. Two expert panels had recommended to the FDA that they not approve the drug until additional studies are completed.

Profound Potential Impact for Families

"Alzheimer's disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research. 

Cavazzoni said past treatments only attempted to treat the dementia symptoms. He said this is the first medication that targets and affects the underlying disease process of Alzheimer’s.

"As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation," Dr. Cavazzoni said. 

Aduhelm attempts to reduce amyloid-beta plaque in the brain, which is a hallmark of Alzheimer's disease. The FDA granted the approval of Aduhelm on the condition that Biogen conducts another clinical trial. 

"This approval is a victory for people living with Alzheimer's and their families," said Harry Johns, Alzheimer's Association president and chief executive officer. 

Drug Attempts to Delay Cognitive Decline

"This is the first FDA-approved drug that delays decline due to Alzheimer's disease. This means individuals may have more time to actively participate in daily life, have sustained independence, and hold on to memories longer. We can experience longer — the relationships we hold most dear — our families and friends," Johns said.

With the FDA approval of this drug, it ushers in a new era in Alzheimer's treatment and research, according to Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer.

"History has shown us that approvals of the first drug in a new category invigorates the field, increases investments in new treatments, and encourages greater innovation. We are hopeful, and this is the beginning — both for this drug and for better treatments for Alzheimer's," Carrillo said.

According to a statement from the Alzheimer's Association, the federal investment in Alzheimer's and dementia research funding is $3.1 billion annually. 

Some Doctors are Wary

Some doctors are saying they will take a wait-and-see attitude with this medication because of past studies; however, there is a tremendous amount of pressure being placed on the medical community for some treatment to help loved ones who require supervision and long-term health care due to Alzheimer's and other dementias. 

The FDA gave Aduhelm the ok under the accelerated approval provisions that provide patients with Alzheimer's early access to the treatment.

However, the FDA's requirement of additional new randomized, controlled clinical trials may get the drug pulled by the FDA if those trials fail to show clinical benefit. There is also some concern that some families may not want their loved ones in the new trials since they could be given the placebo. 

Alzheimer’s Major Reason for Long-Term Health Care

Cognitive decline is one of the major reasons people require long-term care services, which cost families hundreds of thousands of dollars since health insurance, including Medicare, pay little or nothing toward this type of care.

Medicaid will pay for long-term care, but an individual must have little or no income and assets to qualify for the program. Long-Term Care Insurance will also pay for this type of care, but you can only obtain coverage before your health declines. 

Too often, many people ignore planning for long-term care until they experience changes in their health, body, or mind. Many of these changes may prevent an individual from getting coverage in the first place. For this reason, many experts suggest considering Long-Term Care Insurance in your 40s or 50s.

Editor's Note

While new treatments and medications for Alzheimer's are always good news, a cure or substantial treatment is decades or more away. Planning for the future costs and burdens of aging is still an essential part of retirement planning.

People require long-term health care for many reasons; dementia is only one of many. We experience changes in our health and bodies as we get older. After age 60, the risk of cognitive decline also increases. The costs of long-term care services continue to rise due to increased demand and demographics. 

The demographics also have an impact on your family. People have fewer children, and often both spouses work, in addition to having their own families. The role of a family caregiver is physically and emotionally demanding as well. 

Your family will not be trained or prepared for being a caregiver and your spouse, who probably is close to your age, is also not in a position to be a full-time caregiver when you get older.

The solution is affordable Long-Term Care Insurance. The benefits are guaranteed and tax-free. You will have access to your choice of quality care in any setting, including in-home care. You will be able to protect your income and assets and reduce the stress and anxiety otherwise placed on your family.

Research Tools on LTC NEWS

Use the many tools on LTC NEWS to help you learn about the available options and tax advantages available for long-term care planning. Start with the Ultimate Long-Term Care Guide

The LTC NEWS Cost of Care Calculator not only shows you current and future costs of long-term health care, but helps you find quality care in your state, shows you available planning options and tax advantages, and more. 

Other resources are available by clicking here.

Find a licensed and qualified specialist to help you find the best coverage at the best value. Be sure the specialist works with the top companies and has extensive experience with policy design, underwriting, and claims.

Find a trusted specialist by clicking here.

Become a Guest Contributor for LTC NEWS

LTC NEWS can help you drive more traffic to your website or blog, improve your SEO, and give you the exposure you deserve. As a guest contributor, you gain a national and worldwide audience. Are you ready to write?

Be sure your article fits the LTC NEWS target audience of adults 40-70.

Topics can include but are not limited to:

  • Aging
  • Caregiving
  • Health
  • Long-Term Care
  • Retirement Planning

There are numerous other related topics, as well. Remember, you can promote yourself, your business, and your website or blog. It must have editorial content exclusive for LTC NEWS and cannot be just an advertisement. It can include links to other sites, and you can share the article link once published on your website or social media.

Email your story idea or article: newsroom@ltcnews.com or click here

Share News with LTC NEWS

Include LTC NEWS in your press release distribution. If your group, organization, business, political committee, etc., have news to share, send it to LTC NEWS. Email -  newsroom@ltcnews.com 

Need to Find Care or Get Help with an LTC Insurance Claim?

LTC NEWS can arrange for free Long-Term Care Insurance claims processing and care coordination. No cost or obligation. If you have a loved one who has a policy and needs care - don't delay. Use the benefits they have in force. 

If your loved one does not have a policy and still needs long-term care, get professional help.

Click here now.

Advertising and Marketing Opportunities on LTC NEWS

Marketing opportunities are abundant for your business available with LTC NEWS. Plus, working with LTC NEWS is affordable and efficient. 

Use LTC NEWS to gain exposure for yourself, drive traffic to your website or blog and improve your SEO.

Reach an educated audience. Readers of LTC NEWS are researching retirement issues, including aging, health, caregiving, and long-term care. 

Other readers seek information for a parent or other loved one who is experiencing declining health or aging issues and require extended care.   

Many marketing opportunities are available, including sponsored content articles. Sponsored content offers you a long-form way to sell yourself, your company, and your ideas.

Learn more about how LTC NEWS can help you market your business, drive traffic, and improve SEO - click here.

Work With a Long-Term Care Specialist
Work With a Trusted Long-Term Care Insurance Specialist
  • Has substantial experience in Long-Term Care Insurance
  • A Strong understanding in underwriting, policy design, and claims experience.
  • Represents all or most of all the leading insurance companies.
Find a Trusted Specialist
Table of Contents
Connect With a Long-Term Care Specialist

Find Affordable Insurance and the Right Coverage.

LTC News Trusted & Verified
Learn More
Search Results