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☆ Alzheimer's drug Leqembi promises to give patients more time, but they face a long road to treatment
▼ + stars: | 2024-09-08 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +15 min

In this article ESALY4523.T-JPBIIB Follow your favorite stocks CREATE FREE ACCOUNTHannah Yoon | The Washington Post | Getty ImagesLeqembi, an Alzheimer's drug from Biogen and Eisai , isn't a cure for the mind-damaging disease. The drug works in part by clearing toxic plaques in the brain called amyloid, a hallmark of Alzheimer's, according to its manufacturers. The Mayo Clinic's center, which began screening patients for Leqembi in October, has 50 to 60 patients currently taking the drug, according to Petersen. The Mayo Clinic's Alzheimer's center similarly stops dosing patients if ARIA appears on an MRI, according to Petersen. Meeks' neurologist, Dr. Wendell Helveston, said a follow-up MRI picked up one small area of bleeding in her brain that didn't cause any symptoms.

Persons: Hannah Yoon, Missie Meeks, Meeks, Leqembi, I'm, haven't, Julio Rojas, Patricia Waldrup, Biogen's, Alzheimer's, Brian B, Bettencourt, Tracey Collins, Collins, Alex Scott, Scott, Medicare enrollees, Neurologists, Ronald Petersen, Jay Reinstein, Michael Robinson Chávez, Petersen, Michael Irizarry, Eisai's, Eisai, Biogen, Eisai's Scott, It's, Rojas, Wendell Helveston, Bobby Pugh, Bessie Pugh, Karen Pulfer Focht Organizations: Washington Post, Getty, CNBC, University of California, San, San Francisco Health, Toronto Star, Medicare, Mayo Clinic Alzheimer's Disease Research, Georgetown University Hospital, Washington , D.C, Mayo, Leqembi, Mayo Clinic, Reuters, ARIA, Hattiesburg Clinic, Ave Locations: Biogen, Ellisville , Mississippi, U.S, San Francisco, Portland , Maine, Boston, South Mississippi, Washington ,, Mayo, Portland, South Portland, Mississippi, Eisai, Bartlett , Tennessee

☆ Eli Lilly Trial Finds Alzheimer’s Drug Can Slow Progress of Disease
▼ + stars: | 2023-05-03 | by ( Gina Kolata | ) www.nytimes.com time to read: +1 min

The drug manufacturer Eli Lilly announced on Wednesday that a clinical trial of an experimental Alzheimer’s drug showed it can slow progress of the feared disease and allow patients to have more time when they can still live independently, performing tasks like cooking meals, going to the store and driving a car. Lilly announced its results, from a trial involving 1,736 patients, in a news release, as required by the Securities and Exchange Commission. The drug, donanemab, is not a cure, but along with two other drugs recently approved by the Food and Drug Administration,it may be a turning point in the long and frustrating quest to find an Alzheimer’s treatment. “These all point in the same direction,” said Dr. Ronald Petersen, the director of the Alzheimer’s Disease Research Center at the Mayo Clinic. He added that the donanemab results were “modest” but “meaningful.” “

☆ Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drug
▼ + stars: | 2023-01-19 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

REUTERS/Mike SegarJan 19 (Reuters) - Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year. That study, Lilly said, would form the basis of donanemab's application for traditional FDA approval shortly thereafter. The FDA can grant "accelerated" approval to drugs based on their impact on a measurement, in this case amyloid brain plaques, likely to correlate with patient response. Donanemab is in the same class as aducanumab and lecanemab, the latter being a treatment for early Alzheimer's that was given accelerated approval by the FDA earlier this month. Sales of amyloid-lowering Alzheimer's drugs, which need to be given by infusion, are expected to be minimal until they receive standard FDA approval.

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.

☆ Eisai, Biogen Alzheimer's drug slows cognitive decline, safety for some becomes focus
▼ + stars: | 2022-11-30 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

The drug, lecanemab, was associated with a type of brain swelling in 12.6% of trial patients, a side effect previously seen with similar drugs. He suggested that could be because homozygous study patients who were given a placebo fared better than expected. Overall, lecanemab patients benefited by 23% to 26% compared with a placebo on these secondary trial goals. Detailed data from the study were presented at the Clinical Trials on Alzheimer's Disease meeting in San Francisco and published in the New England Journal of Medicine. Dr. Howard Fillit, chief science officer at the Alzheimer’s Drug Discovery Foundation, said doctors always balance the benefits and risks of therapies.

☆ New Alzheimer's drug slows cognitive decline by 27%, clinical trial finds
▼ + stars: | 2022-09-28 | by ( Cheryl Teh | ) www.businessinsider.com time to read: +3 min

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.

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.

Shares of Biogen and Eisai were halted, but shares of Eli Lilly & Co , which is also developing an Alzheimer's drug, were up 6.7% in after hours trade. Aduhelm was the first new Alzheimer's drug approved in 20 years after a long list of high-profile failures for the industry. Symptomatic brain swelling was seen in 2.8% of those in the lecanemab group and none of the placebo group, they said. 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. Other plaque-targeting antibodies in late-stage development for Alzheimer's patients include Roche Holding AG's (ROG.S) gantenerumab and Eli Lilly's donanemab.

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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