The U.S. Approves Its First New Alzheimer’s Drug In 20 Years

Someone in the U.S. is diagnosed with Alzheimer’s disease every 65 seconds; in 2020, it was estimated that 5.8 million Americans aged 65 or older had the condition. These startling statistics are made all the more unsettling by the fact that there is currently no known cure, and few effective treatments, for the disease. But there might be good news on that front: for the first time in nearly 20 years, a new treatment for Alzheimer’s disease has been approved for use in the United States by the U.S. Food and Drug Administration (FDA). Aducanumab, known by the brand name Aduhelm, targets dementia, the underlying cause of Alzheimer’s. But while U.S. manufacturer Biogen, Inc, creator of the drug, has found that the drug works well in higher doses, use of the drug has been narrowed after the FDA received criticism for approving it.  

The Approval

two caucasian hands with their thumbs up
The FDA collaborated with Biogen, the creator of the Alzheimer’s drug, and fast-tracked the drug’s approval.

Aducanumab has had a somewhat rocky approval process. In March 2019, late-stage trials involving 3,000 patients were halted when it was determined that the drug was not slowing down deterioration in participants. However, after Biogen and the FDA worked together to further analyze the data, they concluded that the drug might actually work; Biogen then began collaborating on the drug with the FDA, who fast-tracked its approval this year. They agreed that the drug targets and reduces amyloid, a protein that forms abnormal clumps in the brain of people with Alzheimer’s, which damages brain cells. 

The FDA said there was “substantial evidence that aducanumab reduces amyloid beta plaques in the brain” and that this “is reasonably likely to predict important benefits to patients.”

The drug would cost roughly $56,000 a year and requires monthly IV infusions. 

The Controversy

The FDA’s approval of the drug has been criticized by many, including members of the FDA’s advisory panel, some of whom resigned in protest, and other drug manufacturers are also voicing their concerns. 

Experts are split on whether the FDA’s fast-tracking of the Alzheimer’s drug is potentially harmful or beneficial. Some think more evidence is necessary to prove that the drug is effective, and others worry that this might mean the FDA will begin to fast-track treatments for other diseases, which could put false hope above solid clinical science, and possibly harm patients. On the other hand, some advocacy groups see this as a possible way to help patients dealing with other diseases: “If the FDA can find a way to be flexible for Alzheimer’s, maybe they can find a way to be flexible for ALS,” said Neil Thakur, chief mission officer at the ALS Association.magnifying glass over a piece of paperThe acting head of the FDA, Dr. Janet Woodcock, has weighed in on the controversy, calling for a government investigation into the contacts between Biogen and some of her agency’s drug reviewers. “We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures,” Woodcock said on Twitter.

After the criticism of the drug’s approval, Biogen has narrowed the use of Aduhelm, recommending the treatment be used for people with mild cognitive impairments. They have asked for an update to the label, stating there is no safety or effectiveness data on treatment at earlier or later stages of Alzheimer’s.

As for now, the debate over the drug’s approval continues: aducanumab is being hailed by patient advocates who are eager for a treatment for Alzheimer’s, while others are saying that clinical trials of the drug are inconsistent and more research is needed. Biogen has now been required to conduct a follow-up study to provide more solid evidence that the drug is actually effective. At the very least, this controversial drug could help boost underfunded dementia research, which would be a win for everyone.

Finally, A Cure For Alzheimer’s? New Drug Testing Gives Hope

Finding a cure for Alzheimer’s has been a battle for scientists and researchers for years. Researchers even created a game that people can play to help detect early stages of Alzheimer’s. There have been many new drugs created to help cure and improve the effects of Alzheimer’s disease, but failed. The latest drug has passed the first phase of human

black outline of a head with puzzle pieces missing
There have been many new drugs created to help cure and improve the effects of Alzheimer’s disease, but failed. Now there is hope with a new drug.

testing. The researchers at Forschungszentrum Jülich and Heinrich Heine University Düsseldorf, in Germany, developed the drug, named PRI-002. The drug can be distributed in tablet or capsule form, and researchers are very hopeful for phase 2 of human testing.

How It Works

The new drug, PRI-002, eliminates the toxic beta-amyloid oligomers, which is the protein that scientists suspect causes Alzheimer’s. These amyloid proteins clump together long before any symptoms appear. Other drugs in the past would stimulate the immune system to attack the amyloid plaques formed. However, PRI-002 directly breaks down the amyloid oligomers themselves. In early animal studies, the drug not only shows promise of preventing the onset of Alzheimer’s but can reverse cognitive decline as well. 

“We were able to show that mice with symptoms similar to Alzheimer’s had an improvement in cognitive performance after treatment with PRI-002,” says Janine Kutzsche, a scientist working on the preclinical studies. “The memory and cognition of the treated mice were significantly improved compared to the placebo group and could no longer be distinguished from the memory performance of healthy mice.”

Phase I

Test tubes with one purple liquid and the other yellow liquid.
A group of healthy volunteers took daily dosages of PRI-002 for 4 weeks. It passed human safety testing because it produced no major effects.

After the mice were given extensive testing and showed promising results, humans were the next to take a trial of the drug to make sure that consumption is safe. A group of healthy volunteers took daily dosages of PRI-002 for 4 weeks. The results showed that this new Alzheimer’s drug passed human safety testing because it produced no major effects, even at the highest dosage.

“The drug concentrations in the blood reached the values that had previously been therapeutically effective in animal models,” says Dieter Willbold, one of the scientists working on the project. “Now we were also able to demonstrate the safety of the compound after four weeks of daily administration.”

The drug is moving into Phase II human clinical trials. It will take years to complete the trial to make sure it is effective and completely safe for humans with Alzheimer’s. Hopefully, this new drug will be the answer we have all been waiting for.