- Biogen has announced it will ask for FDA approval for its new drug aducanumab to treat Alzheimer’s disease.
- In phase III clinical trials, the drug shows promise in slowing down plaque buildup in the brain.
- It’s uncertain when the FDA will make a decision on aducanumab, but for experts in the Alzheimer’s field, the new drug produces hope for a new treatment.
Deanna Bullard quit a job she loved in a city she adored and moved home to Virginia to create every memory she could with her father, Don, before Alzheimer’s disease stole his memory for good.
Today, her 63-year-old father is deep into the disease and has no memory of his daughter or most of his life.
Still, Bullard celebrated the news that pharmaceutical giant Biogen is pushing forward with a project they’ve been developing for years.
It’s a drug called aducanumab that researchers believe can extend the memory of people battling Alzheimer’s by clearing harmful plaques from the brain.
“It’s too late for us,” Bullard, 27, told Healthline. “But I’ve seen firsthand what this disease does not just to the person fighting it, but to their family, their friends, really, their entire world. I know there is no way to help my dad anymore, but if this can help others, that would be a game changer.”
That could just be the case.
Biogen has moved the drug through phase III clinical trials and is now pushing for approval from the Food and Drug Administration (FDA).
The timing isn’t known yet, nor is the long-term impact of the drug on people with Alzheimer’s disease.
Still, there’s reason to celebrate, says Keith Fargo, PhD, director of scientific programs and outreach at the Alzheimer’s Association.
“It’s hard to describe this as anything other than good news,” he told Healthline. “Are we sure it is going to work? Are we sure it will sail through the FDA? No. The picture is a little unclear.”
What is clear to Fargo and others hoping for an Alzheimer’s breakthrough: The announcement translates to hope.
“The key point to the public is this,” Fargo said. “Right now, there are no drugs for Alzheimer’s that slow down or stop progression. So here, for the first time ever, we have a potential disease-modifying drug. This is a first in history. We’ve never gotten this far before.”
What Biogen says their trials prove the drug can do is complicated.
Researchers believe that plaque buildup on the brain is a key factor in the slow down and eventual loss of brain function in people with Alzheimer’s.
Aducanumab, given in a high-dose monthly infusion, seems to slow that process down.
In their press release, Biogen researchers said they found a 23 percent less decline on one measure of thinking skills and smaller declines in others.
They plan on releasing more details, including safety information, at a press conference planned for December.
Dr. Gayatri Devi, a neurologist and psychiatrist at Northwell Health in New York who specializes in memory disorders, and author of “The Spectrum of Hope: An Optimistic and New Approach to Alzheimer’s Disease and Other Dementias,” says she can see how that could work.
“It appears that the deposits of plaque in the brain along with the tangles that are found within the nerve cells lead to acceleration of nerve cell death, resulting in symptoms of dementia,” Devi told Healthline. “It is unclear if the plaques are actually sequestering harmful substances or if they themselves are harmful to nerve cells. In any case, reducing the components that form the plaque is helpful in keeping the brain healthy longer.”
But Devi warns that the nuances of Alzheimer’s — a disease that presents uniquely in just about every person — probably means more study and work needs to be done for this to be effective on a broad spectrum of people.
“Alzheimer’s disease is a heterogeneous disease, which means that there are many subtypes and kinds of Alzheimer’s and that to determine if a drug is effective we need to be able to better delineate the subtypes,” she said. “Appropriate dosing and tailoring of the drug to the individual patient is going to be important for successful drug trials in Alzheimer’s disease.”
As they await more details, the Alzheimer’s community in general is feeling hope again, something that had been waning in recent years.
That despair was felt acutely in March when Biogen initially decided to halt its phase III trials for aducanumab.
“There had been a lot of hand wringing recently,” said Fargo, “and a feeling that perhaps we need to retrench a bit.”
But at a recent international conference on the disease — one he anticipated being more somber — Fargo said he felt hope, confidence, and a certain buzz. Now, with Biogen’s latest announcement, that positive feeling is increasing.
“Look,” he said, “this drug may or may not get approved, and even if it does, it’s not a cure. But it’s progress. So, the work continues.”
It also shows, he said, the value in people with the disease and family members participating in clinical trials.
More than 3,000 people participated in trials for this drug to this point, and more are needed for more trials in the pipeline. The Alzheimer’s Association has a program that links volunteers to trials.
For now, Biogen says they plan on releasing the drug to people who were in the trials soon.
Could aducanumab work for those in the early phase of their diagnosis to slow down memory loss and give them and their loved ones more time to cherish?
If it does, even those past the point of this helping, like Bullard, will cheer.
“To give someone the chance to build more memories? I would love that for anyone who has to face this,” she said. “And you know, because of my Dad, my sister and I are more at risk. I hope for drugs and treatments to make this easier, but to cure it for good, too.”
And Bullard had one more thought should aducanumab come to market.
“It has to be affordable,” she said. “It would be a travesty to have this available but out of reach for some.”