TAMPA, Fla. — The Food and Drug Administration has granted accelerated approval to the experimental drug lecanemab, shown to slow down the progression of Alzheimer’s disease in its early stages. 

The highly anticipated decision was made on Friday, with the FDA citing the drug’s phase two clinical trials as enough evidence to move forward.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Dr. Billy Dunn, the FDA’s director of the Office of Neuroscience, in a statement. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

According to the Alzheimer’s 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.

“Today’s decision from the FDA is a huge win for all Floridians. This treatment has the potential to change the course of the disease in a clinically meaningful way for those in the earliest stages of Alzheimer’s,” said Stefanie Thompson Wardlow, a senior program manager for the Alzheimer’s Association Florida Chapters. 

In a more recent phase three trial, lecanemab, a monoclonal-antibody, was shown to reduce cognitive decline in the early stages of the disease by 27 percent.

55-year-old Sury Veliz, of Key Largo, participated in that latest trial. She was diagnosed with Alzheimer’s disease in 2020, after her daughters began noticing her forgetfulness.

“They just kept telling me, mom, you keep forgetting things, and I was like oh man, I’m doing the same thing that my dad was doing,” Veliz said. “And that’s when I freaked out.”

Veliz started the trial within weeks and now, just over two years later, said she got a call from her doctors telling her the amyloids in her brain had all but disappeared. 

“I can’t stop crying. I really can’t,” Veliz said. “I am so happy,”

Still, the drug does come with some safety concerns, including brain swelling and bleeding.

A report released just this week by the New England Journal of Medicine shows a possible link between lecanemab and the death of a woman participating in the trial. That woman reportedly went to the emergency room after showing early signs of a stroke. The report suggests lecanemab, combined with a drug to treat blood clots, may have led to brain hemorrhaging.  

However, neurologist Dr. Sharon Cohen, one of the investigators for the trial, considers the report inconclusive, saying the blood clotting drug, tPA, comes with its own risks, independent of lecanemab. 

“To say that it was from lecanemab, that’s not clear at all,” Dr. Cohen said. “When you give a stroke patient tPA, there’s a known risk of hemorrhage without lecanemab. So I think the narrative is sort of blown out of proportion here.”

Still Cohen, who is the Director of the Toronto Memory Program, said it’s important to select patients for lecanemab who are at low risk of hemorrhage. She also stressed the need for patients to go over the benefit to risk ratio with their doctor.

“And that’s true with most drugs. We have to look at the patient as an individual and see if this drug is right for them,” Cohen said. “Are they at the right stages of the drug? Do they have any reasons the drug might not work for them or might not be safe for them?”

If ultimately considered a candidate for the drug, Veliz urges patients to consider the treatment, calling herself proof it has the potential to work.

“This is hope. We have to embrace this hope and get on this bandwagon and everybody just go for it,” Veliz said. “Because it’s going to help a lot of people.”

Eisai, the drugs lead developer, will market lecanemab under the name Lequembi, with a price tag of 26,500 dollars a year.

As of right now, the Center for Medicare and Medicaid Services will not provide coverage for the drug, except for those participating in clinical trials. This is based on a decision made by the agency back in April, that affected lecanemab’s more controversial predecessor Aduhelm.  Following the FDA’s decision Friday, CMS said its examining available information and may reconsider its current coverage based on that review.

“Alzheimer’s disease is a devastating illness that affects millions of Americans and their families,” said CMS Administrator Chiquita Brooks-LaSure, in a statement. “At CMS, we will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes.”