The Food and Drug Administration (FDA) approved a new medication on Monday for Alzheimer’s disease despite questions about its effectiveness from experts. Aducanumab, or its brand name Aduhelm, is the first Alzheimer’s drug to be approved by the FDA in 18 years. This medication is a monthly intravenous infusion intended to slow cognitive decline in brains with mild memory and thinking problems. It targets a sticky compound in the brain that plays a role in cognitive decline called amyloid-beta.
However, some of Alzheimer’s experts and people from the FDA’s independent advisory committee say that there isn’t enough evidence to show that this drug can thoroughly help patients. They also stated that even if it could effectively slow down cognitive decline in Alzheimer’s disease, there are still issues regarding the drug causing swelling and bleeding in the brain in the clinical trials.
How the Drug was Approved
Patient advocacy groups had lobbied strongly for a potential treatment for the debilitating disease that is inflicting six million people in the U.S. There are so few treatments available for Alzheimer’s and they have high hopes for Aducanumab. However, there is still a limited amount of evidence showing the effectiveness of this new drug.
The FDA agency reportedly approved it through a program called accelerated approval. This program is designed to provide access to potentially valuable therapies for patients with serious diseases.
Michael Vounatsos, chief executive of Biogen, the medication’s manufacturer, praises the approval. “We are committed to sharing our future insights about Aduhelm with the scientific community as we collect more data from the real-world use of this treatment,” he says.
Why are Experts Skeptical about the Drug
Part of the controversy behind Aduhelm’s lack of evidence proving it could treat Alzheimer’s effectively lies in two Phase 3 trials of it. Reportedly, the results from these trials contradicted each other. One trial showed that the drug slightly slowed cognitive decline while the other didn’t show any benefits. Also, these trials were stopped early by a data monitoring committee, and over a third of the participants were never able to complete them.
Insufficient evidence about the drug’s benefits from these trials has led many experts to be concerned about this drug. Some scientists are even concerned that this drug’s approval could lead to more drugs being put on the market before experts are confident about them.
“There’s so little evidence for effectiveness,” said Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, who helped conduct one of the aducanumab trials. He added, “I don’t know what caught the F.D.A.’s fancy here.”
Biogen is expected to launch the drug quickly through more than 600 medical sites expected to administer it. For more information about Aducanumab, visit the FDA website.
What do you think? Do you think it’s acceptable for the FDA to approve an Alzheimer’s drug that lacks substantial evidence that it could effectively treat the disease? Would you trust this drug for your loved one battling Alzheimer’s? Please share your opinions in the comments section below. As always, be sure to like or share this post with someone who has a loved one battling Alzheimer’s disease.
