Aduhelm (generically known as aducanumab) was officially approved in 2021 as a new IV treatment for Alzheimer’s. It will be provided by the pharmaceutical giant powerhouse combination of Biogen/Eisai.
Aduhelm was approved via the FDA Accelerated Approval Program, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. There still remains some uncertainty about the drug’s clinical benefit. New clinical trials will continue to refine our understanding of this new medicine, while the general public may begin treatment as soon as it can be manufactured and delivered.
Aduhelm Aducanumab is a ‘first’
This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.
Aducanumab addresses Alzheimer’s in a new way compared to currently approved drugs.
This therapy slows progression of the disease, rather than only addressing symptoms. It is the first approved therapy of this type; it demonstrates that removing amyloid from the brain may delay clinical decline in people living with Alzheimer’s. Amyloid is the protein that clumps into sticky brain plaques that are a hallmark of Alzheimer’s disease.
“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.
“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.”
Essential to ensure access for all
“This FDA drug approval ushers in a new era in Alzheimer’s treatment and research,” said 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.”
“The Alzheimer’s Association will do everything in its power to ensure access to the drug for all who will benefit,” said Joanne Pike, Dr.P.H., Alzheimer’s Association chief strategy officer. “We know that infusion therapies have been made available under Medicare and insurance for conditions like cancer and multiple sclerosis, so it is reasonable to expect this for aducanumab.”
Benefits outweigh risks
At present, the federal investment in Alzheimer’s and dementia research funding is $3.1 billion annually.
“We examined the clinical trial findings with a fine-tooth comb, we solicited input from the Peripheral and Central Nervous System Drugs Advisory Committee, we listened to the perspectives of the patient community, and we reviewed all relevant data,” the FDA said.
“In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”
The Alzheimer’s Association provided the initial seed money for the development of amyloid PET scans that made this clinical trial possible.
FURTHER INFO:
- For Aduhelm prescribing information and warnings, click here.
- For more on the Alzheimer’s Association, visit the Alzheimer’s Association online, or call the 24/7 Helpline at 800.272.3900.
- Comments by the U.S. Food and Drug Administration on the FDA’s Decision to Approve New Treatment for Alzheimer’s Disease.
SOURCE:
