ROCHESTER, N.Y. (WROC) — The U.S. Food and Drug Administration Monday approved the first drug, aducanumab, that they say could slow the onset of Alzheimer’s disease.
The Alzheimer’s Association says this is the drug that can buy more time with loved ones, and offer a chance to give treatment to the disease in its early stages. But some doctors Monday, saying while this is a big step, they are holding back a bit on celebrating.
“This is the first time that I get to say there is a potential treatment out there,” says Teresa Galbier, Chapter Executive of the Alzheimer’s Association of Rochester and Finger Lakes.
Galbier has been with the Alzheimer’s Association for nearly 20 years. The FDA approving aducanumab today for those in the early stages of Alzheimer’s, a first. She says while not a cure, it could mean more time.
“And how awesome to buy time with our families and our loved ones,” she says.
Doctors today at Rochester Regional Health saying the approval for this drug was controversial, some of the data in the trials ‘murky’. Dr. David Gill saying it still comes with a lot of questions.
“So there’s a lot going on with this announcement,” says Gill.
Dr. Marla Burns says for her future patients, aducanumab is going to be a closely examined case by case recommendation. “But there are a lot of questions surrounding this,” says Burns.
And they say there are potential side effects. “Is it going to be worth the risk? There are risks with this medicine including swelling and bleeding of the brain,” says Gill.
Either way, Galbier says this is never before seen hope for those in the early stages of Alzheimer’s, and a day to celebrate. “This is a first. How awesome to give them the choice to make that informed risk.”
The association said some signs of early Alzheimer’s include memory loss, paranoia, getting lost, and mood changes.
Full statement today from the Alzheimer’s Association of America:
“The Alzheimer’s Foundation of America (AFA) always holds out hope that new medications, if found to be safe, effective, and approved by the FDA, will become available to help the millions of families and individuals affected by Alzheimer’s disease. Today’s accelerated approval of Aducanumab by the FDA, the first new Alzheimer’s drug on the market in nearly two decades, provides hope as another important step in the fight against Alzheimer’s disease. We are hopeful that it will improve the quality of life for individuals living with Alzheimer’s disease and their caregivers. Patient access and affordability to all of those in need is of significant importance. Under the accelerated approval provisions, which provide patients with earlier access to the treatment, the FDA is requiring a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug. Of course, the FDA’s actions do not signal the finish line in the fight against Alzheimer’s disease. It is essential for the federal government to continue building upon the actions it has taken to increase Alzheimer’s research funding, expand caregiver support services and strengthen America’s ‘dementia infrastructure’ to enhance the diagnosis and treatment of Alzheimer’s disease.”
Alzheimer’s Foundation of America Statement on FDA Approving First New Alzheimer’s Medication in Nearly 20 Years