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.