The fight to end Alzheimer’s disease hit a significant benchmark Monday with the first ever Food and Drug Administration approved treatment for the underlying biology of the disease.
The drug, called aducanumab, will go by the brand name Aduhelm. It is the first new Alzheimer’s treatment in 18 years and also the first to attack the disease process.
“While certainly not a cure, this is the first ever FDA-approved treatment for the underlying biology of Alzheimer’s, not just the symptoms,” Harry Johns, Chief Executive Officer of the Alzheimer’s Association, said in a statement.
“Slowing progression for those with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease or Alzheimer’s dementia in its earliest stage offers the potential for more precious time for diagnosed individuals and their loved ones.”
Aducanumab’s aim is to remove sticky deposits of a protein called amyloid beta from the brains of patients who are dealing with the early stages of Alzheimer’s disease. The decline in cognitive skills include memory loss and the ability to care for one’s self.
The timing comes as welcome news during challenging times. Alzheimer’s and dementia deaths have increased 16 percent during the COVID-19 pandemic, according to the Alzheimer’s Association. An estimated 6.2 million Americans of all ages are living with Alzheimer’s disease in 2021.
Biogen, the manufacturer, estimates that roughly 1.5 million Americans would be eligible for the newly approved treatment, given by monthly infusion.
U.S. regulators green lighted aducanumab despite controversy over mixed clinical trial results. The FDA granted approval with the stipulation that the manufacturer conduct a new clinical trial.
But that process could take several years. During that time, the drug will be available for patients. If the secondary study (called a Phase 4 trial) fails to show the drug is effective, the FDA has the option of rescinding approval.
Still, it is a welcome step in addressing a disease that has ravaged so many families.
“It is important to acknowledge that this FDA-approved treatment slows progression (in a limited population) of MCI due to AD and early Alzheimer’s dementia,” Dr. Maria Carrillo, Chief Science Officer for the Alzheimer’s Association, said in a statement.
“It does not stop decline or improve cognition. But it represents an important step and progress in Alzheimer’s science. We recognize that — as with all drug therapies — there can be heterogeneity in treatment effects. More research will be needed to better understand the benefits, side effects and best application.”