The experimental drug Lecanemab, which aims to slow down the progression of Alzheimer’s disease, is awaiting approval by the FDA, a decision that is expected early next month.


What You Need To Know

  • The FDA expected to make its decision on the experimental Alzheimer's disease drug, Lecanemab, by January 6, 2023

  • The drug, a monoclonal antibody, reduces cognitive decline in the early stages of the disease by 27%

  • While the anticipation of Lecanemab’s approval is providing hope, the drug does come with some safety concerns, including brain swelling and bleeding

Researchers say the drug is showing promise, more so than its predecessor Aduhelm, which made headlines earlier this year when Medicare severely limited its coverage. Now, advocates expect Lecanemab to fare better with regulators.

A phase three study shows that the drug, a monoclonal antibody, reduces cognitive decline in the early stages of the disease by 27%. 

“The reason why we’re super, super excited is the fact that we now have more data that says, 'You know what, you’re looking for more proof.' Well, now you have it,” said Keith Gibson, a research champion with the Alzheimer’s Association.  

According to the association, about 6.5 million Americans age 65 and older are living with the disease.  Without the development of breakthrough treatments, that number is projected to nearly double by the year 2050.

While the anticipation of Lecanemab’s approval is providing hope, the drug does come with some safety concerns, including brain swelling and bleeding.

That’s one of the reasons why Bobby Marshall of Ruskin opted not to participate in the trial. He was diagnosed with Alzheimer's disease at the age of 55, but with a history of migraines, had concerns over an increased chance of stroke.

“We decided it wasn’t worth the risk to me,” Marshall said.

However, the now-63-year-old still hopes regulators give Lecanemab the green light, for the sake of others who the drug could help.

“It’s not on the same scale, but it’s kind of like getting a cure for cancer,” Marshall said. “If you keep going forward, if you can find something that’s going to slow the progression or prevent it, absolutely.”

Lecanemab is currently under accelerated review and a decision by the FDA is expected by January 6, 2023.