The drug, Leqembi, is the first that’s been convincingly shown to slow the decline in memory and thinking that defines Alzheimer’s by targeting the disease's underlying biology. The
Leqembi, from
“This drug is not a cure. It doesn’t stop people from getting worse, but it does measurably slow the progression of the disease,” said Dr.
Snider stressed that the medicine, pronounced “leh-KEM-bee,” comes with downsides, including the need for twice-a-month infusions and possible side effects like brain swelling and bleeding.
Approval came via
Last week, a congressional report found that
Scrutiny of the new drug, known chemically as lecanemab, will likely mean most patients won’t start receiving it for months, as insurers decide whether to cover it and for whom.
The drug will cost
Some 6 million people in the
The
Since then,
The larger study tracked patients’ results on an 18-point scale that measures memory, judgment and other cognitive abilities. Doctors compile the rating from interviews with the patient and a close contact. After 18 months, patients receiving Leqembi declined more slowly — a difference of less than half a point on the scale — than patients who received a dummy infusion. The delay amounted to just over five months.
There is little consensus on whether that difference translates into real benefits for patients, such as greater independence.
“Most patients won’t notice the difference,” said Dr.
Schrag and some other researchers believe a meaningful improvement would require at least a difference of one full point on the 18-point scale.
Leqembi works by clearing a sticky brain protein called amyloid that’s a key indicator of Alzheimer’s. But it’s not clear exactly what causes the disease. A string of other amyloid-targeting drugs have failed and many researchers now think combination treatments will be needed.
Aduhelm, the similar drug, was marred by controversy over its effectiveness.
The FDA approved that drug in 2021 against the advice of the agency's own outside experts. Doctors hesitated to prescribe the drug and insurers restricted coverage.
The FDA did not consult the same expert panel before approving Leqembi.
Rep.
Schrag said many of the same concerns apply to both drugs.
“Is this slight, measurable benefit worth the hefty price tag and the side effects patients may experience?” he asked. “I have pretty serious doubts.”
About 13% of patients in Eisai’s study had swelling of the brain and 17% had small brain bleeds, side effects seen with earlier amyloid-targeting medications. In most cases those problems didn’t cause symptoms, which can include dizziness and vision problems.
Also, several Leqembi users died while taking the drug, including two who were on blood-thinning medications.
Insurers are likely to only cover the drug for people like those in the company study — patients with mild dementia and confirmation of amyloid buildup. That typically requires expensive brain scans or a spinal fluid test. Doctors will need to perform a different type of scan to periodically check for brain swelling and bleeding.
A key question in the drug’s rollout will be insurance coverage by Medicare, the federal health plan that covers 60 million seniors and other Americans. The agency severely restricted coverage of Aduhelm, essentially wiping out its U.S. market and prompting Biogen to abandon marketing plans for the drug.
“Once we have a Medicare decision, then we can truly launch the drug across the country," said
Her initial diagnosis, based on a cognitive examination, was later confirmed by a positive test for amyloid.
Groves, of
“For me, the minute that drug comes on the market — and I get my doctor’s approval — I’m going to take it,” Groves said.
AP Medical Writer
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