Why experts say a promising new Alzheimer’s drug is different

BURLINGTON, Vt. (WCAX) - As soon as July, the FDA will decide whether a new Alzheimer’s medicine should get the official greenlight, according to an announcement from the manufacturer this week.

Leqembi received a conditional OK in January, but the traditional stamp of approval would knock down a daunting barrier-- cost.

Leqembi falls into a new category of Alzheimer’s drugs that recent research shows could slow the progression of the disease.

A Boston-based geriatric psychiatrist whose participation in a clinical study helped put Leqembi on the market explained how the treatment works and why it’s different than other Alzheimer’s drugs.

“This new class of medications, which are called anti-amyloid therapies or disease-modifying therapeutics, actually alter the underlying biology of the disease,” said Dr. Brent Forester of McLean Hospital.

Forester says previous drugs have only tackled the symptoms of the disease.

Leqembi removes substances in the brain that scientists believe are at the root of the irreversible, debilitating disorder. They’re called sticky amyloid plaques.

“These amyloid plaques show up somewhere between 15 and 20 years before any symptoms of memory loss or functional decline even occur in an individual,” Forester explained.

This antibody therapy is administered intravenously twice a month to patients with early Alzheimer’s disease experiencing mild cognitive impairment or dementia. Each infusion lasts for about an hour.

Forester’s team at McLean is one of several across the country that conducted an 18-month clinical trial with a total of about 1,800 patients. Half received Leqembi, the other half a placebo.

Together, researchers published their findings in the New England Journal of Medicine in November, documenting that amyloid plaques in the brains of patients taking Leqembi were almost completely gone.

“The real important question for anyone with this illness and their family members is: does getting rid of amyloid matter? Does it matter in terms of symptoms and functioning over time? And the answer seems to be: it does matter,” Forester said.

Forester explained that scientists aren’t quite sure how plaque buildup in the brain influences symptoms, but they know they’re connected. The study concluded Leqembi patients’ cognitive decline was reduced by nearly one-third.

“It’s a really big deal and we’re super excited, and we feel that excitement amongst our community,” said Meg Polyte, the policy director of the Vermont Alzheimer’s Association.

Of the estimated 6 million Americans with Alzheimer’s, at least 13,000 live in Vermont, according to the state’s Alzheimer’s Association chapter.

Polyte said while Leqembi isn’t a cure, it offers the gift of time.

“For them to be with family, complete some things on their bucket list, get their finances in order,” Polyte said.

Forester said the FDA’s accelerated approval is based purely on Leqembi’s success in eradicating those plaques, not on its safety. The drug carries the risk of brain swelling and bleeding, especially for patients on blood thinners.

And though Leqembi is technically on the market, access is extremely limited. The Centers for Medicare & Medicaid Services has refused to cover the cost until Leqembi gets full FDA approval.

The current price tag is more than $26,000 a year out of pocket.

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