The Food and Drug Administration has just approved the first new drug for Alzheimer’s in nearly 20 years, despite numerous objections from the medical community.
For years, Alzheimer’s patients have relied on medications that relieve their symptoms, such as anxiety and insomnia. The new drug is considered a potential game-changer when it comes to slowing cognitive decline, but not everyone is onboard. Expect plenty of disagreement between doctors and providers in the years to come.
Does Aduhelm Work?
The new drug, known as Aduhelm, is administered every four weeks. It was developed by Biogen and Eisai Co., a Japanese company. The drug hasn’t been shown to prevent Alzheimer’s, but one study suggests it can delay the progression of the disease by reducing harmful clumps of plaque that form in the brain.
The drug helps remove beta-amyloid, a protein linked to Alzheimer’s. It’s made of living cells that must be administered via infusion at the doctor’s office. Many experimental drugs have done the same, but they didn’t have any effect on a patient’s memory or ability to think for themselves.
During the study, Alzheimer’s patients taking Aduhelm saw their thinking skills decline 22% more slowly than patients taking a placebo treatment, but the effects were minimal, and it’s not clear how these benefits will play out in real-world situations, such as with self-care, communication, and cognitive awareness.
Part of the problem is that researchers still don’t fully understand what causes Alzheimer’s. Reducing beta-amyloid in the brain may help curb dementia, but studies suggest family history, education, and chronic diseases like heart disease can play a role as well.
“This is just one piece of the puzzle, and I think all these other options need to be explored and amplified,” said Dr. Ronald Petersen, a specialist at the Mayo Clinic, who has studied dementia for years and consulted with Biogen during the study.
As part of the approval process, the FDA is asking Biogen to conduct a follow-up study to confirm the drug will ultimately benefit Alzheimer’s patients. If the drug fails to pass the test, the government could pull it from the market, but the agency rarely goes to such extremes.
Biogen has yet to confirm the retail price of the drug, but experts say a year’s worth of supply could range from $30,000 to $50,000. A cost-benefit analysis shows the drug should range from $2,500 to $8,300 per year based on the assumed health benefits of the drug. However, the Institute for Clinical and Economic Review noted that “any price is too high” if Aduhelm doesn’t prove effective in the follow-up study.
In 2019, Biogen halted two studies of the drug after it didn’t show the desired results. The company then reversed course several months later by showing that the drug was effective at higher doses, prompting the FDA review process.
Despite the approval, several questions remain, such as how long patients will benefit from the drug, how will physicians decide when to discontinue the drug, and whether the drug can benefit patients with more advanced dementia.
Dueling Points of View
The drug is quickly becoming one of the most controversial in the country. Advocates for Alzheimer’s patients and caregivers say that any benefit warrants FDA approval.
“It is a new day. This approval allows people living with Alzheimer’s more time to live better,” Harry Johns, CEO of the Alzheimer’s Association, said in a statement. “For families, it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease. It is about hope.”
The number of seniors at risk of developing dementia is expected to rise dramatically over the next several years as the baby boomers continue to age and retire. As more patients and family members search for effective treatment, drugs like Aduhelm may soon become the norm.
However, experts in the field are criticizing the FDA’s decision to greenlight the drug. They say approving the Biogen drug sets a dangerous precedent, opening the door for more experimental Alzheimer’s drugs with uncertain benefits to hit the market.
In November, an outside group of panelists advising the FDA said that there wasn’t sufficient evidence to show the drug worked. They pointed out several “red flags” in the data, including the fact that some patients didn’t see any initial improvement until a second analysis performed later. The FDA isn’t obligated to follow the outside panel’s advice.
Panelist Dr. Joel Perlmutter with Washington University School of Medicine said, “Alzheimer’s treatment is a huge, urgent, unmet need. But if we approve something with data that is not strong, we have the risk of delaying good, effective treatments.”
Others say qualifying for the drug will be difficult for some patients. Providers and specialists will require a brain scan, which can cost as much as $5,000, before prescribing the drug.
Aduhelm also comes with potentially serious side effects. Around 40% of patients that participated in the clinical trial experienced painful brain swelling as well as headaches, nausea, and fatigue. Patients will need to be monitored for potential side effects, which may require additional brain scans. If swelling occurs, treatment can continue “with caution only after a clinical evaluation and a follow-up MRI demonstrates radiographic stabilization,” according to the label.
Nearly 6 million Americans are already living with the disease, according to the Alzheimer’s Association. That number is expected to rise to 13 million by 2050.
After the news was announced, Biogen shares jumped nearly 60% in the stock market. Despite the uncertainty surrounding Aduhelm, treating Alzheimer’s means big business.