ALZHEIMER'S DRUG: 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. MORE:
Leqembi, from Japan's Eisai and its U.S. partner Biogen, is a rare success in a field accustomed to failed. The delay in cognitive decline brought about by the drug likely amounts to just several months, but Dr. Joy Snider and some other experts say it could still meaningfully improve people's lives.
Last week, a congressional report found that FDA's approval of a similar Alzheimer's drug called Aduhelm — also from Biogen and Eisai — was "rife with irregularities," including a number of meetings with drug company staffers that went undocumented. Since then, Eisai has published the results of a larger 1,800-patient study that the FDA will review to confirm the drug's benefit, paving the way for full approval later this year.
Schrag and some other researchers believe a meaningful improvement would require at least a difference of one full point on the 18-point scale. Insurers are likely to only cover the drug for people like those in the company study — patients with mild symptoms and confirmation of amyloid buildup. That typically requires expensive brain scans. A separate type of scan will be needed to periodically monitor for brain swelling and bleeding.A key question in the drug’s rollout will be the coverage decision by Medicare, the federal health plan that covers 60 million seniors and other Americans.
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