(WSYR-TV) — For the first time in decades, the FDA has given accelerated approval for a drug that could be used to treat those with Alzheimer’s disease. It’s called Aducanumab or Aduhelm, and it’s administered through an IV.
It’s not on the market just yet, but it’s getting attention because it’s the first treatment to claim to modify Alzheimer’s disease. Other medications that exist silence symptoms and do not slow the progression of the disease.
With this accelerated approval, the FDA is requiring that Biogen, the company that created the drug, complete another clinical trial to prove its clinical benefit. This will likely happen while the drug is on the market. If the FDA finds that the drug’s symptoms do not outweigh the benefit, it has the right to revoke the approval.
In the initial trial, the drug was tested on people with mild cognitive impairment, not those with severe dementia. But to those with The Alzheimer’s Association, this is an important step in treating the disease, which there’s still no cure for.
“For people that may be eligible for this treatment, it could mean more time. More time that they could be independent, more time with their family, more time enjoying the things that they are able to do out in the community,” said Cathy James, CEO of the Alzheimer’s Association, Central New York Chapter.
Plus, it’s been nearly two decades since new medication has been created to help those suffering from Alzheimer’s disease. James said this will be a catalyst for more research.
“When we have new treatments that are in a particular class, which this is a new class of treatment it’s a disease-modifying drug, this opens up the door for new treatments,” James said. “So I think this will be the start of seeing opportunities for other disease-modifying drugs.”
And an opportunity to spread awareness about the need for early detection when it comes to Alzheimer’s disease.
But when it comes to some members of the medical community, they still have questions about this treatment.
“Many of us physicians in the field feel it was made without full data. It was based on data from a study that had been stopped. Because it didn’t show any benefit,” said Dr. Sharon Brangman, Chair of Department of Geriatrics at Upstate University Hospital. “But when they took another look at the higher dose they thought there was some benefit.”
Dr. Brangman, who has studied Alzheimer’s disease for more than 30 years, said she thought those recent developments would be cause for the drug company to pick back up on the trials. But then, Biogen submitted the new information to the FDA for accelerated approval.
“Also, the drug doesn’t work unless you have high levels of this abnormal protein called amyloid in the brain. And this medicine works by breaking down those amyloid clusters because they tangle up all the nerves,” Dr. Brangman said. “And what we want to know is, when those clusters of amyloid are removed, is the brain working better? And is somebody going to have a delay in the progression of their Alzheimer’s disease?”
While it’s not on the market yet, Dr. Brangman and her colleagues are now preparing to potentially roll out this new treatment. It’s going to take a lot of education for families, testing to see if patients have the amyloid build-up in the brain, and MRI and PET scans, which are not always covered by insurance.
“I’ve been working with patients with Alzheimer’s disease for more than 30 years and we know how desperate people are to have something that will make a difference,” Dr. Brangman said.
However, many physicians don’t feel they have enough data to really tell how great that difference is just yet.
Still, this treatment is offering hope that families haven’t experienced in decades.
“As a family, if there’s a chance that you get another Christmas or another, you know, more memories, you know with your loved one, how do you not take it,” said Mary Koenig, whose father died of Alzheimer’s disease in 2019.
If you have any questions, those with the Alzheimer’s Association recommend reaching out to your doctor. You can also call their 24/7 helpline any time at (800) 272-3900.