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TOKYO (AP) — Japan's health ministry has approved Leqembi, a drug for Alzheimer’s disease that was jointly developed by Japanese and U.S. pharmaceutical companies. It's the first drug for treatment of the disease in a country with a rapidly aging population. Developed by Japanese drugmaker Eisai Co. and U.S. biotechnology firm Biogen Inc., the drug's approval in Japan comes two months after it was endorsed by the U.S. Food and Drug Administration. Eisai said it will conduct a post-marketing special use survey in all patients administered the drug until enough data is collected from unspecified number of patients under Japanese health ministry procedures. Eisai is committed to delivering Leqembi to people who need it and their families “as a new treatment,” said Haruo Naito, the company’s CEO.
Persons: Fumio Kishida, Kishida, Eisai, Leqembi, , Haruo Naito Organizations: TOKYO, Biogen Inc, U.S . Food, Drug Administration, Kyodo Locations: Japan
In a press release in late September announcing that Eisai’s experimental Alzheimer’s drug had significantly slowed progression of the memory-robbing disease, the company’s chief executive officer, Haruo Naito , was anything but circumspect. The results from the late-stage study, he said, “prove the amyloid hypothesis.”The announcement, which said the drug lecanemab reduced cognitive and functional decline by 27% compared with placebo, surprised investors and scientists alike. It helped add more than $30 billion in combined market value for the stock of Biogen —which shares economic rights to the drug—and Eli Lilly , which is testing another closely watched anti-amyloid.
A clinical trial of a new Alzheimer's drug from Eisai and Biogen has shown promising results. The large-scale study saw cognitive decline in patients being slowed by 27% over 18 months. The trial involved 1,795 patients with early-stage Alzheimer's. The companies announced the trial's success in a press release on Tuesday, saying their drug — called lecanemab — was observed to have slowed cognitive decline in Alzheimer's patients by 27% over 18 months. The companies noted that around 21% of the patients who received the lecanemab treatment experienced brain swelling that was visible on PET scans.
CNN —A monoclonal antibody treatment for Alzheimer’s disease called lecanemab slows the progression of cognitive decline by 27% compared with a placebo, drugmakers Biogen and Eisai said Tuesday. Alzheimer’s is a very heterogeneous disease.”But he says that does not diminish the potential significance of the trial. “In the past, reducing amyloid in the brain has not always been tied to cognitive improvements or any meaningful clinical improvements. Biogen is also the company behind another Alzheimer’s drug, Aduhelm, which was controversially approved by the FDA in June 2021. Aduhelm was the first new Alzheimer’s drug approved in nearly 20 years, but there were questions about its efficacy and cost.
Globally, the figure could reach 139 million by 2050 without an effective treatment, Alzheimer's Disease International said. Aduhelm was the first new Alzheimer's drug approved in 20 years after a long list of high-profile failures for the industry. read morePatient advocacy groups hailed the news of positive lecanemab trial results. Micro hemorrhages in the brain occurred at a rate of 17% in the lecanemab group, and 8.7% in the placebo group. Aduhelm's approval was a rare bright spot for Alzheimer's patients, but critics have called for more evidence that amyloid-targeting drugs are worth the cost.
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