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☆ GE Healthcare has been an under-the-radar winner — and a new catalyst just arrived
▼ + stars: | 2024-09-30 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +6 min

Wall Street currently sees GE Healthcare earning $6.72 per share in 2028, according to FactSet, up from $4.25 projected this year. GE Healthcare has been a stock we've been battling since its steep slide during the second quarter. That dynamic — coupled with the positive China stimulus announcements in recent days — turned GE Healthcare into one of our top-performing stocks in the third quarter . A PET scan using Flyrcado has better diagnostic efficacy than SPECT scans, according to GE Healthcare. GE Healthcare may also see a recovery in its China business due to the roll out of medical-focused stimulus spending .

Persons: Wells, Flyrcado —, Wells Fargo, Flyrcado, FactSet, Jim Cramer, —, Jim, Leqembi, Eli Lilly, Stifel, Jim Cramer's, Yi Haifei Organizations: GE Healthcare, GE, Food and Drug Administration, Wall, FDA, Federal, Club, CDC, Management, CNBC, Fair for Trade, Services, China National Convention Center, China News Service, Getty Locations: China, U.S, Beijing

☆ 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

☆ Patients on Alzheimer's drug Leqembi see benefits over three years, Eisai study says
▼ + stars: | 2024-07-30 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The newly FDA approved Alzheimer's treatment Leqembi is prepared at Abington Neurological Associates in Abington, PA., on Tuesday, November 7, 2023. The breakthrough Alzheimer's drug Leqembi slowed disease progression in patients over three years, demonstrating the need for them to stay on the treatment long term, according to new data released Tuesday by Japanese drugmaker Eisai. The study results on Leqembi, which Eisai shares with Biogen , also found that a patient's Alzheimer's disease worsens after they stop treatment. The results are a first glimpse at what Alzheimer's patients' future could look like on therapies such as Leqembi, which is currently taken twice a month through an infusion. By 2050, the number of Alzheimer's patients is projected to rise to almost 13 million in the U.S.

Persons: Lynn Kramer, Leqembi, Eisai, Kramer Organizations: FDA, Abington Neurological Associates, Biogen, CNBC, Alzheimer's Association International Conference, Alzheimer's Association Locations: Abington, Abington , PA, U.S, Philadelphia

☆ European drug regulator rejects Alzheimer's treatment Leqembi from Biogen, Eisai
▼ + stars: | 2024-07-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

European drug regulators on Friday rejected the Alzheimer's treatment Leqembi from Biogen and Eisai , creating another hurdle for the companies as they scramble to boost uptake of the therapy in the U.S. But it almost always follows the drug regulator's recommendations. The European Medicines Agency's human medicines committee recommended against granting marketing authorization for Leqembi. Leqembi and Kisunla are milestones in the treatment of Alzheimer's after three decades of failed efforts to develop medicines that can fight the fatal disease. In 2021, the European Medicines Agency rejected Aduhelm.

Persons: Eisai, Leqembi, Eli Lilly, Kisunla, Aduhelm Organizations: U.S, European Commission, U.S . Food, Drug Administration, Medicines, European Medicines Agency, Alzheimer's Locations: Biogen, U.S, Japan, South Korea, China, Israel, Europe, Alzheimer's Europe

☆ What Eli Lilly investors can learn from the slow launch of a competitor's drug
▼ + stars: | 2024-02-15 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +8 min

Club holding Eli Lilly is expecting to get approval for its Alzheimer's treatment in the coming weeks, but investors looking for immediate financial success should temper their expectations. The FDA's decision on Lilly's drug, known as donanemab, is expected by the end of March. In the meantime, Eli Lilly's diabetes and obesity drugs, the heart of our investment thesis, should continue to fuel the lion's share of the company's topline growth. About 2,000 patients are currently taking Leqembi, Biogen said Tuesday, up from 800 at the time of the company's third-quarter report in November. LLY YTD mountain Eli Lilly's stock performance so far in 2024.

Persons: Eli Lilly, drugmaker Biogen, Eli Lilly's, —, Lilly, Biogen, Japan's, Chris Viehbacher, Viehbacher, Morgan Stanley, Lilly's, Donanemab, Mounjaro, Jim Cramer, Leqembi, Jim Cramer's, Jim Organizations: Food and Drug Administration, Drug Administration, Alzheimer's Association, FDA, Club, GE Healthcare, FactSet, Pharmaceutical, CNBC Locations: Indianapolis

☆ Exclusive-Eisai Expects 1,500 Alzheimer's Patients in China Launch, Sees ‘Huge’ Growth
▼ + stars: | 2024-02-04 | by ( Feb. | At P.M. | ) www.usnews.com time to read: +5 min

“China is one of the fastest-aging countries in the world and is one of the most important countries in the area of Alzheimer’s disease for Eisai,” a company spokesperson said. “The potential growth for Leqembi in China is huge.”Eli Lilly, which is developing a similar treatment called donanemab, told Reuters it has filed for approval in China. The Indianapolis-based company is now testing its drug in a 1,500-person trial with volunteers in China, Taiwan, South Korea and the EU, a spokesperson said. Leqembi, which works by removing a toxic protein called beta amyloid from the brain, is the first Alzheimer's treatment proven to alter the course of the fatal, brain-wasting disease. Once on treatment, suitable patients undergo a series of MRI scans to monitor for potentially fatal swelling and bleeding in the brain.

Persons: Julie Steenhuysen, Andrew Silver CHICAGO, ” Eli Lilly, Biogen, Liu Zhou, Eisai, ”, Hidemaru Yamaguchi, Soeren Mattke, Mattke, Andrew Silver, Caroline Humer, Bill Berkrot Organizations: Reuters, EU, Leqembi, Guangdong Medical University, ” Citi, Psychiatry, Siemens Healthineers, University of Southern, University of Southern California Brain Health Locations: SHANGHAI, China, ”, Leqembi, The Indianapolis, Taiwan, South Korea, Eisai, United States, Japan, Europe, U.S, University of Southern California, Chicago, Shanghai

☆ Pfizer's twice-daily weight loss pill joins a long list of obesity drug flops
▼ + stars: | 2023-12-02 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

That includes Novo Nordisk 's Wegovy and diabetes treatment Ozempic as well as Eli Lilly 's diabetes drug Mounjaro. They have all skyrocketed in popularity — and slipped into shortages — over the last year for safely and successfully causing significant weight loss. But before the current weight loss industry gold rush, the path to treating obesity was strewn with failures dating back decades. In its full-year 2019 earnings, Eisai reported that Lorcaserin had sales of $28.1 million in the U.S. for the year. Sanofi's rimonabantAn obesity drug called rimonabant from Sanofi and Aventis was withdrawn from all markets in 2008 due to the risk of serious psychiatric problems, including suicide.

Persons: Eli Lilly, drugmakers, lorcaserin, Eisai, Lorcaserin Organizations: Getty, Pfizer, Novo Nordisk, U.S, Drug Administration, FDA, Aventis, Abbott Laboratories Locations: U.S, Sanofi

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai/Handout via REUTERS/File Photo Acquire Licensing RightsBOSTON, Oct 25 (Reuters) - An injected version of Eisai (4523.T) and Biogen's (BIIB.O) Alzheimer's drug Leqembi works as well as the current intravenous version at removing toxic brain plaques, according to an analysis presented by Eisai on Wednesday. The Japanese drugmaker's review compared data for 72 patients with early Alzheimer's given Leqembi by subcutaneous injection to prior pivotal trial results from 898 patients who received the drug by infusion. Blood concentration levels of the drug were 11% higher with subcutaneous Leqembi than the IV version. Roll-out of IV Leqembi, which has an annual list price of $26,500, has been slow.

Persons: Eisai, Leqembi, ”, Eric Reiman, Priya Singhal, Biogen, Michael Irizarry, Alzheimer's, Julie Steenhuysen, Deena Beasley, Bill Berkrot, Leslie Adler Organizations: Reuters, REUTERS, Rights, Banner Alzheimer's Institute, ARIA, Thomson Locations: Handout, Boston, Los Angeles

☆ Blood tests needed for widespread Alzheimer's diagnosis on the way
▼ + stars: | 2023-10-11 | by ( Deena Beasley | ) www.reuters.com time to read: +6 min

Several Alzheimer's blood tests are in the works – and one is already being sold to consumers – but none have been established as accurate, formally approved by regulators or reimbursed by insurers. Researchers have been working for years on blood tests for Alzheimer's that can replicate these diagnostic tools. The need for blood tests has become more pressing since the FDA approved Leqembi in July. Accurate blood tests are expected to help identify which dementia patients actually have Alzheimer’s, the most common but not the only cause of dementia. "When there are widely available, scalable, sensitive and specific blood tests it will be an absolute game changer for Alzheimer's patients."

Persons: Denis Balibouse, Eli Lilly, Dr, Sarah Kremen, Eliezer Masliah, Eisai, Michael Irizarry, Roche, Bruce Jordan, Russ Paulsen, Deena Beasley, Caroline Humer, Bill Berkrot Organizations: Memory Centre, of Readaptation, University Hospital, REUTERS, FDA, Sinai Medical Center, Wednesday, Quest Diagnostics, National Institute, Aging, U.S . National Institutes of Health, C2N Diagnostics, Roche Diagnostics, Alzheimer's Association, RAND, Thomson Locations: Geneva, Switzerland, Leqembi, Eisai, Los Angeles, U.S

☆ Insight: Promising new Alzheimer's drugs may benefit whites more than Blacks
▼ + stars: | 2023-07-31 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +11 min

The company told Reuters that 49% of Black volunteers did not meet the trial's amyloid threshold requirements compared to 22% for whites and 55% for Hispanics. "Is it because MCI (mild cognitive impairment) or early dementia type-symptoms in Blacks are caused by other reasons more so than Alzheimer's?" In 96 dementia trials from 2000-2017, diverse populations only made up around 11% of enrollment, according to a 2018 study. Among Black people who died of Alzheimer's, their dementia was more likely to result from multiple causes, such as vascular disease. "Is it that it's not Alzheimer's disease?

Persons: Barrington, Vickie Riley, Charlie, Harriet Shaffer, Barrington Riley, –, Eli Lilly, Lilly, Crystal Glover, Eisai, Ivan Cheung, Cheung, Shobha, Biogen, Mark Mintun, Alzheimer's, Dr Lisa Barnes, Barnes, Joshua Grill, we're, Reisa Sperling, Brigham, Julie Steenhuysen, Caroline Humer, Suzanne Goldenberg, Daniel Flynn Organizations: Emory University Brain Health, Americans, Reuters, Prospective Black, Rush, Disease Research, and Drug Administration, FDA, Black, MCI, National Institutes of Health, Rush Center, University of California, Women's Hospital, Thomson Locations: Atlanta , Georgia, U.S, Chicago, Tokyo, Irvine, United States

☆ Acumen's Alzheimer's drug passes initial safety test
▼ + stars: | 2023-07-16 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +2 min

CHICAGO, July 16 (Reuters) - An experimental Alzheimer's disease drug developed by Acumen Pharmaceuticals (ABOS.O) targeting a novel form of the toxic protein beta amyloid in the brain passed an early safety test and will advance to a larger trial, the company said on Sunday. The drug, ACI193, was well tolerated in the first trial testing it in people, the company said. Results of the randomized, placebo-controlled study of 62 patients with early Alzheimer's disease were presented at the Alzheimer's Association's International Conference in Amsterdam. In the Acumen trial, 10.4% of treated participants (5 people) developed a brain swelling condition known as ARIA-E associated with amyloid-targeting treatments. Acumen said the study suggests the drug can be given as a monthly intravenous infusion.

Persons: Eric Siemers, Leqembi, Julie Steenhuysen, Bill Berkrot Organizations: Pharmaceuticals, Thomson Locations: Amsterdam, Alzheimer's

☆ Top 10 things to watch in the stock market Friday including a jobs shocker
▼ + stars: | 2023-07-07 | by ( Jeff Marks | ) www.cnbc.com time to read: +5 min

Paramount (PARA) downgraded to underperform from peer perform (sell from hold), with a $14 price target by Wolfe Research. Wells Fargo reiterates Club name Disney (DIS) as a Signature Pick with a $147 price target but cuts its earnings-per-share (EPS) estimates. Morgan Stanley raises its price target on Ford (F) to $16 from $14 and General Motors to $41 from $38 on higher earnings estimates. Ferrari (RACE) remains Morgan Stanley analyst Adam Jonas' Top Pick as he raises his RACE price target to $340 from $310. MoffettNathanson raises its price target on card companies: Mastercard (MA) to $490 from $460 and Visa (V) to $320 from $290.

Persons: Nonfarm, Bond, Leqembi, fave Eli Lilly, donanemab, Eli Lilly, Baird, downgrades Wells, Wolfe, Morgan Stanley, Wells, JPMorgan downgrades, Elon Musk's, Mark Zuckerberg's, Ferrari, Adam Jonas, Jim Cramer's, Jim Cramer, Jim Organizations: FDA, Medicare, Medicaid Services, fave, Costco, Food, U.S, Wolfe Research, downgrades, JPMorgan, WFC, Humana, Dow, Meta, Paramount, Disney, Ford, Motors, Mastercard, Jim Cramer's Charitable, CNBC Locations: United States, downgrades Wells Fargo

☆ FDA approves Alzheimer’s drug Leqembi, paving way for broader Medicare coverage
▼ + stars: | 2023-07-06 | by ( Spencer Kimball | ) www.cnbc.com time to read: +8 min

Leqembi is the first Alzheimer's antibody treatment to receive full FDA approval. The antibody, administered twice monthly through intravenous infusion, targets a protein called amyloid that is associated with Alzheimer's disease. Medicare coverage is a crucial step to help older Americans with early Alzheimer's disease pay for the treatment. Costs may vary depending on whether the patient has supplemental Medicare coverage or other secondary insurance, according to the agency. Philipson and his colleagues at the University of Chicago estimated that delaying Medicare coverage of Alzheimer's antibody treatments by one year would result in $6.8 billion in increased spending.

Persons: Joanna Pike, Leqembi, Pike, David Knopman, Knopman, Anna Eshoo of, Nanette Barragan, There's, Tomas Philipson, Bush, Philipson, Sen, Bernie Sanders, Xavier Becerra, Sanders, Eisai Organizations: Drug Administration, Medicare, FDA, Alzheimer's Association, Mayo Clinic, Services, Health, University of Chicago, Senate Health, Human Services, Clinical Locations: U.S, Minnesota, Anna Eshoo of California

Trial data showed that the treatment slows progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer's. The FDA placed its strongest "boxed" safety warning on Leqembi's label, flagging the risk of potentially dangerous brain swelling for Alzheimer's drugs in the same class. Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients. Biogen and Eisai stock has risen since FDA granted accelerated approval to Alzheimer's drug Leqembi earlier this yearLeqembi's new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies. The first FDA-approved disease-modifying Alzheimer's drug, Aduhelm, was also developed by partners Eisai and Biogen, but Medicare coverage restrictions have severely limited its use.

Persons: Leqembi, drugmakers, Ivan Cheung, Chiquita Brooks, LaSure, Babak Tousi, Tousi, Biogen, Dr, Erik Musiek, Eli Lilly, Co's, Cheung, Joanne Pike, Eisai, Leqembi's, Deena Beasley, Julie Steenhuysen, Bill Berkrot, Matthew Lewis Organizations: U.S . Food, Drug Administration, FDA, Medicare, Medicaid Services, Cleveland Clinic, Washington University, Barnes, Jewish, Alzheimer’s Association, Alzheimer's Association, Thomson Locations: ANGELES, U.S, Los Angeles, Chicago

☆ Medicare offers details on reimbursement for new Alzheimer's drugs
▼ + stars: | 2023-06-22 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

CHICAGO, June 22 (Reuters) - The U.S. Medicare health plan on Thursday offered details of plans to collect patient data as a condition for reimbursement for Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) new Alzheimer's drug Leqembi, should it win traditional U.S. approval as expected by July 6. If it wins traditional FDA approval, Leqembi would be the first disease-modifying drug ever to achieve the regulatory milestone. Current treatments only treat symptoms but do not change the course of the disease, which affects 6 million Americans, according to the Alzheimer's Association. On that basis, CMS said it would only pay for Leqembi if patients were enrolled in a clinical trial. The CMS data requirements apply to all Alzheimer's treatments that reduce beta amyloid from the brain, including Eli Lilly and Co's donanemab, which recently reported positive results from its late-stage trial.

Persons: Biogen, Eisai's Leqembi, Leqembi, Eli Lilly, Co's, “, Robert Egge, Julie Steenhuysen, Daniel Wallis Organizations: U.S, Eisai Co, Centers, Medicare, Medicaid Services, CMS, Alzheimer's Association, U.S . Food, Drug Administration, FDA, Alzheimer’s Association, Thomson Locations: U.S

All six advisers on the panel voted in favor of Leqembi for treatment of the mind-wasting illness. That approval would also make Leqembi the first disease-modifying drug ever to achieve the regulatory milestone. Leqembi won accelerated approval by the FDA in January based on its ability to remove sticky amyloid plaques from the brain. Most U.S. Alzheimer's patients are Medicare-eligible. “We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks."

Persons: Eisai, Leqembi, Tanya Simuni, Robert Alexander, Joanne Pike, Leroy Leo, Khushi, Julie Steenhuysen, Bill Berkrot Organizations: Food and Drug Administration, Alzheimer's Association, FDA, Northwestern University Feinberg School of Medicine, Banner Alzheimer's Institute, CAA, Medicare, Wall Street, Analysts, Alzheimer's, Thomson Locations: Leqembi, U.S, Bengaluru, Chicago

☆ Bernie Sanders says price of Alzheimer's treatment is unconscionable, calls on HHS to take action
▼ + stars: | 2023-06-07 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Sen. Bernie Sanders on Wednesday called on the U.S. Health and Human Services Department to take action to ensure seniors can actually afford the expensive Alzheimer's treatment Leqembi. Sanders, who chairs the Senate Health Committee, in a letter to HHS Secretary Xavier Becerra called the $26,500 annual price tag for Leqembi set by drugmakers Eisai and Biogen "unconscionable." Sanders said the "outrageously high price" of Leqembi "will prevent seniors who need this drug from receiving treatment." Most Medicare patients suffering from Alzheimer's would not be able to afford the 20% co-payment of more than $5,000 a year for Leqembi, Sanders said. Co-payments, along with coinsurance and deductibles, are medication and health services costs that patients must personally pay for out of pocket, as opposed to being covered by their health insurance.

Persons: Sen, Bernie Sanders, Sanders, Xavier Becerra, drugmakers Eisai, Becerra, Mr Organizations: U.S, Capitol, U.S . Health, Human Services Department, Health, Medicare, HHS, Services, Leqembi, Democratic, Senate, Clinical Locations: Washington , DC, Vermont

☆ Bipartisan attorneys general call on Medicare to cover Alzheimer's treatments
▼ + stars: | 2023-05-01 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Democratic and Republican attorneys general in nearly half of U.S. states are calling on Medicare to provide unrestricted coverage of antibody treatments for Alzheimer's disease, according to a letter released Monday. "We ask that CMS provide unrestricted Medicare coverage for FDA-approved Alzheimer's treatments, consistent with its decades-long practice of covering FDA-approved prescription drugs for Medicare beneficiaries," the attorneys general, led by Oklahoma's Gentner Drummond, told CMS Administrator Chiquita Brooks-LaSure and Health Secretary Xavier Becerra. More than 70 House lawmakers and 18 senators called on Medicare to provide unrestricted coverage of Alzheimer's treatments in February. The push by members of Congress and state attorneys general comes after Medicare rejected a request by the Alzheimer's Association to cover Leqembi without any conditions.

☆ Alzheimer’s patients may wait years to get treated with new drugs, putting them at risk of more severe disease
▼ + stars: | 2023-04-30 | by ( Spencer Kimball | ) www.cnbc.com time to read: +17 min

But time spent waiting robs early patients of their memory and ability to live independently. This condition is often, though not always, a sign of early Alzheimer's disease. PET scans cumbersomeTwo types of tests can diagnosis Alzheimer's disease: PET scans and spinal taps. Early Alzheimer's disease can also be diagnosed with a spinal tap, in which fluid around the spinal cord is extracted with a catheter and tested. He believes big players like CVS will provide infusions for Alzheimer's disease on a major scale if they see there's a large and stable market.

☆ Alzheimer's: Medicare will cover Leqembi for all patients if FDA approves drug, CMS chief says
▼ + stars: | 2023-04-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Medicare will cover the new Alzheimer's treatment Leqembi for all patients eligible under the medication's label if the Food and Drug Administration fully approves the drug in July, a federal official told members of Congress on Wednesday. Brooks-LaSure faced pointed criticism from Democrat and Republican members of the House Subcommittee on Health over Medicare's controversial coverage policy for new Alzheimer's treatments. The Food and Drug Administration approved Leqembi, which is a collaboration by Biogen and Eisai antibody treatment, on an expedited basis in January. But Medicare, which primarily provides health coverage to senior citizens, currently will only cover the majority of costs for Leqembi for patients participating in federally approved clinical trials. "When FDA approves the drug, whichever populations they say it is appropriate for, that will be the basis of which people will get the drug," she said.

☆ Eli Lilly Alzheimer's treatment solanezumab failed to slow disease progression
▼ + stars: | 2023-03-09 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Eli Lilly on Wednesday said it will halt development of its Alzheimer's treatment candidate solanezumab after the antibody failed to slow disease progression. The study enrolled more than 1,000 seniors who had normal memory and thinking function, but showed signs of brain plaque that is associated with Alzheimer's. Lilly said it did not have that data because donanemab cleared brain plaque quickly in many patients. "We remain confident in the of potential donanemab as a new treatment for people with early symptomatic Alzheimer's disease," Skovronsky said. The FDA approved Eisai's and Biogen's early Alzheimer's treatment Leqembi on an expedited basis in January.

☆ Eisai, Biogen say FDA grants priority review for Alzheimer's drug Lecanemab
▼ + stars: | 2023-03-06 | by ( ) www.reuters.com time to read: 1 min

TOKYO, March 6 (Reuters) - Japanese drugmaker Eisai Co Ltd (4523.T) and its U.S. partner Biogen Inc (BIIB.O) said on Monday that the U.S. Food and Drug Administration granted priority review for traditional approval of their Alzheimer's treatment Lecanemab. The FDA accepted Eisai's supplemental Biologics License Application for the drug, supporting transition from the accelerated approval granted in January, the drugmaker said in a statement. Reporting by Rocky Swift; editing by Diane CraftOur Standards: The Thomson Reuters Trust Principles.

☆ Medicare rejects Alzheimer's Association request for unrestricted coverage of treatments like Leqembi
▼ + stars: | 2023-02-23 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Due to the drug's high price and Medicare's coverage restrictions, seniors are unable to access the treatment. The letter the Alzheimer's Association sent to CMS in December calling for unrestricted coverage was signed by more than 200 researchers and experts. CMS said it would provide broader coverage of Leqembi on the same day should the FDA fully approve the treatment. Medicare adopted the coverage restrictions after controversy over the Alzheimer's antibody treatment Aduhelm, which was also developed by Eisai and Biogen.

☆ Maker of promising Alzheimer's drug Leqembi expects full FDA approval this summer, expanded Medicare coverage
▼ + stars: | 2023-02-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

Early Alzheimer's typically hits people ages 65 and older, causing cognitive impairment and other issues. Medicare beneficiaries who agree to participate in CMS-backed research studies, which are broader than clinical trials, would get coverage if Leqembi receives full approval. Drug rollout will take yearsIf everything goes according to Eisai's expectations, the FDA would grant full approval and CMS would provide unrestricted coverage of Leqembi. In that scenario, Eisai anticipates that about 100,000 diagnosed early Alzheimer's patients will be eligible by year three of the drug's rollout. Private insurers are largely waiting for a CMS coverage decision though some may decide to make their coverage decisions earlier, he said.

☆ Senators call on Medicare to offer broad coverage of Alzheimer's treatments as public pressure grows
▼ + stars: | 2023-02-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

U.S. senators on Friday called for Medicare to offer broad coverage of Alzheimer's treatments approved by the Food and Drug Administration, warning that current restrictions cost patients precious time as their disease progresses. The 20 senators told CMS that Alzheimer's will cost the nation $1 trillion by 2050 if the U.S. does not take decisive action. As a consequence, Medicare coverage for the expensive drug is basically nonexistent. The Alzheimer's Association wrote CMS in December calling for the agency to provide unrestricted Medicare coverage for Leqembi. "We believe Medicare beneficiaries should have unimpeded access, broad and simple access to Leqembi because the data fulfill those criteria."

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