WASHINGTON , November 6(AP):

One of the biggest drug decisions in decades is looming as U.S. regulators consider whether to approve the first medicine that’s claimed to slow mental decline from Alzheimer’s disease, the most common form of dementia.

A panel of outside experts meets Friday to advise the Food and Drug Administration on aducanumab, a drug from Cambridge, Massachusetts-based Biogen Inc. and Japan’s Eisai Co. FDA doesn’t always follow the panel’s advice but usually does and has until March to decide.

The drug does not cure or reverse Alzheimer’s; the claim is that it modestly slows the rate of decline.

The evidence is murky: The companies stopped two studies last year when the drug didn’t seem to work, then did an about-face and said additional results suggest it was effective in one study at a high dose. Results still have not been published.

An FDA staff report released Wednesday gave a generally glowing view, saying the positive study might be “exceptionally persuasive.” But an FDA statistician noted flaws and inconsistencies in the results and potential safety issues.

The drug is expected to be very expensive and “could bankrupt our health care system” while giving patients false hope, the consumer group Public Citizen warned.

More than 5 million people in the United States and many more worldwide have Alzheimer’s. Current drugs only temporarily ease symptoms and the last one was approved nearly two decades ago.

The FDA evaluation focuses on safety and effectiveness. But advocates for approval, including the Alzheimer’s Association, are pushing to make need part of the decision.

“There is a dire and drastic need” to help people impacted “by the crushing realities” of the disease, the association wrote to the FDA. The association got $450,000 from Biogen and Eisai last year, less than 1% of its total revenue.

Others say the need for a drug has no bearing on whether it works or is safe.

“This is a difficult decision. I think it’s going to be contentious no matter how it falls out,” said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation, who consults for Biogen.

ABOUT THE DRUG

Aducanumab (pronounced “add-yoo-CAN-yoo-mab”) aims to help clear harmful clumps of a protein called beta-amyloid from the brain. Other experimental drugs have done that but it made no difference in patients’ ability to think, care for themselves or live independently.