- The FDA approved Aduhelm (aducanumab), a drug that helps fight early Alzheimer’s disease.
- This is the first drug approved to fight Alzheimer’s disease in nearly two decades.
- It might not work — and it’s expensive.
A new drug is here to fight Alzheimer’s disease — but with optimism comes skepticism.
The Food & Drug Administration approved Aduhelm (aducanumab) on Monday. Made by biotechnology company Biogen, Aduhelm was given the green light under the accelerated approval pathway, which allows patients suffering from a serious disease to have access to drugs earlier for the clinical benefit — despite there being unknowns about the benefit.
“This approval is a victory for people living with Alzheimer’s and their families,” Harry Johns, Alzheimer’s Association president and chief executive officer, said after the FDA approval.
While some experts might be calling this a monumental step in treating early Alzheimer’s disease, there’s plenty of controversy surrounding Aduhelm, the first novel therapy passed for Alzheimer’s disease since 2003.
From the drug’s effectiveness to it’s eye-watering price, here’s what you need to know about Aduhelm.
Does Aduhelm work — and why is it so controversial?
The first drug approved to fight Alzheimer’s disease in nearly two decades, Aduhelm attacks clusters of toxic protein that are believed to destroy neurons and cause dementia.
It’s the first time a drug has shown progress in reducing plaques — or beta-amyloid — that can be found in the brains of those suffering with Alzheimer’s. Administered through infusion every four weeks, the drug is a bit of a mystery and lab results have been inconsistent, which is why its been marred with controversy.
In 2019, Biogen and its partner Eisai halted two Phase 3 clinical trials of aducanumab after an independent monitoring committee said that the drug failed to meet expectations. Shortly after the stalled trial, Biogen released another analysis that showed patients who received high doses of the drug had a reduction in clinical decline, according to CNN.
Biogen said last year that patients treated with a high dose of the drug showed 22% less clinical decline in their cognitive health over an 18-month period.
By the summer of 2020, Biogen submitted paperwork to the FDA for approval of the drug. The mixed results were enough of a red flag that an expert panel rejected Biogen’s new Alzheimer’s drug due to insufficient evidence proving that aducanumab works.
When the advisory committee voted against the drug back in November, their main position was that only one of two trials showed positive results, which isn’t a strong enough argument considering the sample size.
“Approving a drug that will be used by potentially millions of desperate Alzheimer’s patients before definitive evidence of effectiveness has been established is likely to result in far more harm than good, leading to false hope for Alzheimer’s disease patients and their families and, if the drug actually is ineffective, setting back other efforts to develop truly effective treatments for many years, if not decades. And our health care system cannot afford to take a chance on such an unproven drug given Biogen’s announced exorbitant over-pricing,” Michael Carome, director of Public Citizen’s Health Research Group said in testimony.
The controversy surrounding Aduhelm become even more apparent when two top neuroscience experts resigned from an FDA advisory committee shortly after the FDA granted approval.
Dr. David Knopman, a neurologist at the Mayo Clinic, resigned as a member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee on Wednesday, Business Insider reported, following Dr. Joel Perlmutter of Washington University, who left the panel on Monday.
The side effects of Aduhelm can be serious
While the potential for the drug — helping fight Alzheimer’s disease — seems bright, there’s been worries about the potential for serious side effects.
The FDA warns that Aduhelm can cause Amyloid Related Imaging Abnormalities (ARIA), a common side effect that doesn’t have any clear symptoms but can be serious. ARIA means swelling in the brain, which can come with “small spots of bleeding in or on the surface of the brain with the swelling.”
Other symptoms include: headache, dizziness, nausea, confusion, and vision changes.
The drug is going to cost a fortune
Biogen said that the drug will cost $56,000 a year for an individual. This is significantly higher than the $10,000 to $25,000 Wall Street analysts expected.
Each infusion — given every four weeks — would be $4,312, based on the average weight of a US patients with mild cognitive impairment or mild dementia.
Biogen said it is “committed to providing access to Aduhelm for patients across a spectrum of financial situations. For qualified, commercially insured Aduhelm patients, co-pay and infusion cost assistance programs may reduce out-of-pocket costs to as low as $0.”