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Signage for Eisai Co. at the company's headquarters in Tokyo, Japan, on Friday, Feb. 3, 2023. Bloomberg | Bloomberg | Getty ImagesShares of Japanese pharmaceutical giant Eisai sank Friday after the company's Alzheimer's drug was formally approved by U.S. regulators overnight, prompting questions over investor sentiment surrounding the move. Eisai shares closed 4.67% lower after paring some of its earlier losses. Leqembi is the first Alzheimer's antibody treatment to receive full FDA approval. "The odds for brain swelling and hemorrhage are far higher than any actual improvement," Espay, who launched a petition in June calling for the Alzheimer's treatment to not get full approval, told NBC News.

Persons: Biogen, Dr, Alberto Espay, Espay, Ivan Cheung, CNBC's, Cheung Organizations: Bloomberg, Getty, U.S, . Food, Medicare, University of Cincinnati College of, NBC News, Eisai U.S Locations: Tokyo, Japan, Eisai

A newly approved Alzheimer's drug will be available to patients in the coming days, according to its maker, the Japanese pharmaceutical company Eisai. While Leqembi offers hope to patients and their families, experts say that there are still some key unanswered questions about the drug, including about its safety and effectiveness. Besides questions about who will benefit the most, there are also questions about how long the drug will benefit patients. About 17% of the Leqembi group experienced brain bleeds, compared with 9% in the placebo group. The reports of brain bleeding and brain swelling "may only be the tip of the iceberg," he said.

A newly approved drug intended to slow the progression of Alzheimer’s disease offers patients hope, but it will come with a steep price tag: $26,500 a year. That drug initially cost $56,000 per year before Biogen slashed the price in half, to $28,000 annually. Dr. David Rind, the institute's chief medical officer, said an appropriate cost for the drug is $8,500 to $20,600 a year. John Domeck, 60, of Aurora, Ohio is currently enrolled in a phase 3 clinical trial testing Leqembi. But right now, the clinical trial for Leqembi shows that the drug provides "modest efficacy at a big, big price," Caplan said.

☆ Experimental Alzheimer's drug: After promising data, experts say many questions remain
▼ + stars: | 2022-10-04 | by ( Brenda Goodman | ) edition.cnn.com time to read: +10 min

CNN —The experimental Alzheimer’s drug lecanemab made big news last week when the companies testing it released trial results that showed the drug met its goals, making it one of the first dementia drugs to return positive results. By some counts, lecanemab is the 16th drug that’s been developed to clear toxic amyloid plaques from the brain. Or did the companies that are testing it – Biogen and Eisai – run a smarter clinical trial that finally showcased the potential of these kinds of medications? Clinical trial results were mixed, with only one showing a small benefit to patients. He says he might change his mind if analysis of the clinical trial shows that one group of people got more of a benefit than others.

The Japanese drugmaker Eisai said Tuesday its experimental drug for Alzheimer’s disease helped slow cognitive decline in patients in the early stages of the illness. The company said that in a phase 3 clinical trial, the drug, called lecanemab, slowed cognitive decline by 27% after 18 months. The results may offer renewed hope to Alzheimer’s patients after the U.S. drugmaker Biogen’s botched rollout of its drug, Aduhelm, last year. Biogen partnered with Eisai in the commercialization of the new drug, although Eisai led its development and the phase 3 trial. Two similar drugs — from Roche and Eli Lilly — are expected to release late-stage clinical trial results over the next few months.

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