The drug is intended to slow the progression of Alzheimer’s disease.
It is not a cure.
The news about Aduhelms approval is both exciting and controversial.
Siriporn Kaenseeya / EyeEm / Getty Images
It’s exciting because it is the first new drug approved to treat Alzheimers since 2003.
Its controversial because its not clear from the clinical trial that the drug will actually work.
Last year, an FDA panel concluded there wasn’t enough evidence to prove the drug was effective.
What Is Alzheimer’s Disease?
Alzheimers diseaseis an irreversible, progressive brain disorder that slowly destroys memory and thinking skills.
Aduhelm works by reducing beta-amyloid plaque, according to the FDA.
The reduction in amyloidrather than an improvement in memory or thinking skillsled to the FDA approval.
And that’s why some experts are concerned.
But the organization was also cautious in its reaction to the significance of the approval.
It’s the first step in the right direction, not an immediate game-changer.
We are hopeful and this is the beginningboth for this drug and for better treatments for Alzheimers.
The panel of experts were members of a voluntary FDA advisory committee.
Will the Drug Work?
Alzheimers experts say the newly-approved drug represents a positive step, though hardly an end to the debilitating disease.
What to Know About Taking Aduhelm
Aduhelm is given as an IV infusion every four weeks.
The drug could cost $56,000 per year, according to Biogen.
During clinical trials, brain swelling was more common in people with a genetic predisposition to Alzheimer’s disease.
It’s a complex equation between drug companies, insurers, pharmacies, and physicians.
Jessica Shepherd, MD
Food and Drug Administration.FDA grants accelerated approval for Alzheimers drug.
Biogen.Biogen and Eisai launch multiple initiatives to help patients with Alzheimers disease access Aduhelm.
