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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

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

☆ 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

TOKYO, June 13 - Japan's benchmark Nikkei gauge surged on Tuesday, closing over 33,000 for the first time in 33 years, led by technology shares on expectations of a flood of investment in chip-related companies. The Nikkei (.N225) climbed for a third-straight session, adding 1.8% to 33,018.65, closing above the key psychological level for the first time since July 1990. Global shares climbed on Monday ahead of closely watched U.S. inflation data on and policy decisions from the Federal Reserve, Bank of Japan, and other central banks. Toyota's EV strategy "was well received by the market, and also last night the U.S. market was strong, so we have a strong market today," said Daiwa Securities strategist Kenji Abe. The auto sector (.TEWP.T) rose 3.4% to become the best performer among the Tokyo Stock Exchange's 33 industry sub-indexes.

Persons: Kenji Abe, Drugmaker Eisai, Rocky Swift, Sonia Cheema Organizations: Nikkei, SoftBank Group Corp, Intel Corp, Advantest Corp, Toyota Motor Corp, Global, Federal Reserve, Bank of Japan, Daiwa, Tokyo Stock, Thomson Locations: TOKYO, U.S

☆ Medicare will require data on patient use for approved Alzheimer's drugs
▼ + stars: | 2023-06-01 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +3 min

Leqembi received accelerated approval from the FDA in January, based on limited evidence suggesting it would slow cognitive decline in early Alzheimer's patients. A panel of FDA advisers will discuss whether Leqembi should receive traditional approval next week, and a decision could come by early July. Medicare, the government health plan for Americans 65 and over, currently pays for Leqembi only if patients are enrolled in a clinical trial. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices rather than drugs. To receive Medicare coverage, people will need to be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer's and have a qualified physician participating in a registry.

Persons: Biogen, Leqembi, Eisai, Eli Lilly, Co's, Eli Lilly's, Alzheimer's, Sue Peschin, Manas Mishra, Leroy D'souza, Bill Berkrot Organizations: U.S, Eisai Co, FDA, Medicare, Centers, Medicaid Services, CMS, Alzheimer’s Association, Alliance for Aging Research, Thomson Locations: Bengaluru

☆ After weight loss, Alzheimer's may be next frontier for drugs like Ozempic
▼ + stars: | 2023-05-08 | by ( Natalie Grover | ) www.reuters.com time to read: +6 min

LONDON, May 8 (Reuters) - Diabetes drugs that also promote weight loss such as Novo Nordisk’s (NOVOb.CO) Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer’s disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs. She said she has since been approached by pharmaceutical companies at an increasing pace, and is currently running an Alzheimer’s trial evaluating intranasal insulin in combination with another diabetes drug. Four companies with GLP-1 drugs, including two larger drugmakers, say they are watching for results of trials testing Novo's drug in Alzheimer's. Dementia affects more than 55 million people globally and the market for Alzheimer’s drugs is expected to grow to $9.4 billion by 2028 and for Parkinson’s to $6.6 billion, according to pharmaceutical data provider Citeline.

The drug, donanemab, met all goals of the trial. "These are the strongest phase 3 data for an Alzheimer's treatment to date," said Maria Carrillo, chief science officer for the Alzheimer's Association. In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of the participants, with 6.1% experiencing symptoms. In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants. It also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.

☆ 'It totally backfired': The pitfalls of Alzheimer's genetic testing
▼ + stars: | 2023-04-21 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +8 min

CHICAGO, April 21 (Reuters) - Wendy Nelson watched her mother slowly die of Alzheimer's disease, unable to move or swallow at the end. When her father's memory began to fail a year later, one of her two sisters doubted it could be Alzheimer's, Nelson said. THE TESTING REVOLUTIONUntil recently, most doctors tended not to order genetic tests to determine Alzheimer's risk, because there were no effective treatments to slow or prevent the disease. US regulators recommend genetic testing before starting treatment with Leqembi. Some members of families with increased genetic risk of Alzheimer's say it might be better not to know at all.

Lilly has not previously discussed its Medicare coverage optimism publicly. The U.S. Centers for Medicare & Medicaid Services (CMS) did not immediately respond to a request for comment. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices. Amyvid, Lilly's Alzheimer's imaging agent that can detect amyloid plaques on PET scans, has been subject to CMS' evidence development program for a decade. "It shuts out many patients," said Dr. Maria Carrillo, chief science officer of the Alzheimer’s Association, "especially minorities and rural patients."

☆ Exclusive: US to build $300 mln database to fuel Alzheimer's research
▼ + stars: | 2023-04-03 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

The platform will draw on data from medical records, insurance claims, pharmacies, mobile devices, sensors and various government agencies, they said. The database could help identify healthy people at risk for Alzheimer's, which affects about 6 million Americans, for future drug trials. The U.S. Medicare health plan for older adults will likely require such tracking in a registry as a condition of reimbursement for Leqembi. Silverberg said the data platform could also help researchers working in other disease areas understand which patients are most at risk and the impact of medications. The system would be built in a secure computing environment with a number of restrictions to ensure the privacy of people's health data, Silverberg said.

☆ Lilly says experimental Alzheimer's drug reduces amyloid in small study
▼ + stars: | 2023-03-31 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

The higher the dose of the antibody drug, which was given by subcutaneous injection, the larger the effect, Lilly said. The Indianapolis-based drugmaker is launching a Phase III study of the experimental antibody, remternetug, but declined to comment on which doses will be selected for larger, later-stage trials. Lilly, at a medical conference in Gothenburg, Sweden, presented interim data from 41 study participants. Trial results published last year showed that, in patients with early Alzheimer's, Leqembi reduced the rate of cognitive decline by 27% compared with a placebo. Brooks said that sharing its early remternetug data "reinforces Lilly's commitment and investment in the Alzheimer's disease space ...

The Alzheimer's Association and the pharmaceutical industry say the drug companies are not directly involved in the campaign. But the Alzheimer's Association says patients simply don't have the time to spare. The agency did not address the Alzheimer's Association campaign. Association members have met 30 times with staffers for the state's 20 members of Congress, Ryan Schiff, the chapter's public policy manager, said. Spokespeople for all three companies said they do not work with the Association on its campaign to expand Medicare coverage of the drugs.

☆ US VA to cover Eisai, Biogen Alzheimer's treatment Leqembi
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +1 min

March 13 (Reuters) - Eisai Co Ltd and Biogen Inc (BIIB.O) said on Monday that the U.S. Department of Veteran Affairs (VA) will provide coverage of their Alzheimer's treatment Leqembi to veterans at an early stage of the memory-robbing disease. Leqembi has so far been approved in the U.S. under the Food and Drug Administration's accelerated review program. The treatment is currently undergoing the FDA's standard review process, which will weigh its impact on cognitive function. Eisai and Biogen have said they expect full U.S. approval for Leqembi by summer or late this year, which would likely open up coverage by Medicare and other health insurers. Reporting by Ahmed Aboulenein in Washington and Pratik Jain in Bengaluru; Editing by Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.

☆ Veterans Affairs to Be First Major Insurer to Cover Alzheimer’s Drug Leqembi
▼ + stars: | 2023-03-10 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

Leqembi is the first anti-amyloid drug shown to slow decline from Alzheimer’s. Eisai Co.’s new Alzheimer’s disease drug Leqembi will be covered by the U.S. Department of Veterans Affairs, the first major insurer to agree to pay for the drug since its approval by U.S. regulators earlier this year. Eisai said Monday veterans with the early stages of Alzheimer’s would get the drug covered under criteria set by the VA.

☆ 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.

☆ FDA neurosciences chief Billy Dunn to leave immediately, analysts raise concern
▼ + stars: | 2023-02-28 | by ( ) www.reuters.com time to read: +2 min

Feb 28 (Reuters) - The U.S. Food and Drug Administration neurosciences head Billy Dunn will retire from his role effective immediately, the health regulator told Reuters on Tuesday. Wall Street analysts said Dunn's departure could impact the regulator's stance on neurological drug decisions in the near term, sending down shares of Reata Pharmaceuticals Inc (RETA.O) 30% on Monday when media reports on the exit surfaced. Texas-based Reata is expecting FDA's decision by Tuesday on its drug to treat a rare neuromuscular disorder called Friedreich's ataxia. The departure of Dunn, 53, was announced in an internal message to the agency's employees on Monday. Newly appointed deputy director Teresa Buracchio will also serve in Dunn's role on an interim basis at the Office of Neuroscience, the agency told Reuters.

☆ Amyloid Gains Converts in Debate Over Alzheimer’s Treatments
▼ + stars: | 2023-02-27 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

The success of Eisai Co.’s new Alzheimer’s drug has helped quiet a decadeslong dispute over a leading theory of what causes the disease and how to treat it, with proponents declaring victory and some former skeptics switching sides. Since the early 1990s, many scientists have thought that removing clumps of a sticky protein called amyloid from the brains of Alzheimer’s patients could help slow the disease, if not stall or reverse it. The theory was an outgrowth of the “amyloid hypothesis,” which held that an abnormal accumulation of brain amyloid was the central trigger in a complex neurodegenerative process leading to Alzheimer’s.

☆ Biogen Boss Turns Corner on Alzheimer’s Miscues
▼ + stars: | 2023-02-15 | by ( David Wainer | ) www.wsj.com time to read: 1 min

After botching the commercialization of its first Alzheimer’s drug, Biogen got a new lease on life with a second one that surprised skeptics of the amyloid hypothesis. The positive news restored investor excitement for its growth potential and allowed the Boston-area biotech to recruit the veteran Chris Viehbacher as its new boss. Now, he is trying to convince investors he can right the ship. That starts with not messing up the rollout of Alzheimer’s drug Leqembi. Mr. Viehbacher has shown he is intent on doing that by, first and foremost, maintaining a good relationship with lead partner Eisai Co Ltd.

☆ Biogen CEO bets on Alzheimer's drug, pipeline to return to growth
▼ + stars: | 2023-02-15 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Feb 15 (Reuters) - Biogen Inc (BIIB.O) Chief Executive Officer Christopher Viehbacher said on Wednesday he is banking on high-profile launches of Alzheimer's disease treatment Leqembi and depression drug zuranolone, as well as deals, to help the company return to revenue growth. A controversial approval and problematic launch of previous Alzheimer's disease drug Aduhelm, which like Leqembi was developed with Eisai Co Ltd (4523.T), have further dented investor sentiment. Biogen is also hoping to gain U.S. approval of depression treatment zuranolone this year. Biogen forecast full-year adjusted profit of $15 to $16 per share, compared with analysts' estimates of $15.72 per share. The company reported a fourth-quarter adjusted profit of $4.05 per share, beating estimates compiled by Refinitiv IBES by 57 cents.

☆ Biogen sees modest 2023 revenue from Alzheimer's disease drug
▼ + stars: | 2023-02-15 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Feb 15 (Reuters) - Biogen Inc (BIIB.O) said on Wednesday that Alzheimer's disease drug Leqembi would bring in modest revenue for the year although it might not be enough to offset costs tied to its launch. Biogen has a 50% share of U.S. profits on Leqembi, which it developed with lead partner Eisai Co Ltd (4523.T). "Over the last couple of years, the company has lost its way somewhat and now it is in a declining revenue," Viehbacher said. Biogen expects full-year adjusted profit of $15 to $16 per share, compared with analysts' estimates of $15.72 per share. The company reported a Q4 adjusted profit of $4.05 per share, above Refinitiv IBES estimates of $3.48 per share.

☆ EU regulator accepts Biogen-Eisai's Alzheimer's treatment lecanemab for review
▼ + stars: | 2023-01-26 | by ( ) www.reuters.com time to read: 1 min

Jan 26 (Reuters) - Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) said on Thursday the European Medicines Agency (EMA) had accepted a marketing authorization application for their Alzheimer's disease drug for review. The drug, lecanemab, was recently granted accelerated approval in the United States. Reporting by Sriparna Roy in Bengaluru; Editing by Subhranshu SahuOur Standards: The Thomson Reuters Trust Principles.

☆ Eli Lilly Alzheimer's drug setback extends rival Biogen's lead - analysts
▼ + stars: | 2023-01-20 | by ( ) www.reuters.com time to read: +2 min

Jan 20 (Reuters) - The U.S. health regulator's rejection of accelerated approval for Eli Lilly and Co's Alzheimer's disease drug extends the market lead for rivals Eisai and Biogen's treatment by months, analysts said. "This is a modest positive for Biogen" because it delays donanemab's launch, Jefferies analyst Michael Yee said, adding that Eli Lilly could file for traditional approval by mid-2023. The setback for Lilly comes just weeks after the FDA granted Biogen Inc (BIIB.O) and Japanese drugmaker Eisai Co Ltd's (4523.T) accelerated approval for their Alzheimer's drug Leqembi. read moreAnalysts are waiting for the traditional approval of Biogen's drug and for wider health insurance coverage before they expect sales of the drug to pick up. "But if there is anything wrong with the (Eli Lilly) data set, it is easier to reject an unapproved drug than remove an approved drug from market," said Skorney.

☆ 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's Alzheimer's drug price should not dent demand, analysts say
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +2 min

Jan 9 (Reuters) - The $26,500-per-year price tag for Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) newly approved Alzheimer's disease drug is slightly above expectations, but should not dent demand for the promising therapy, Wall Street analysts said. The U.S. health regulator on Friday granted accelerated approval to the drug, Leqembi, and the decision was hailed by patient groups. However, the price tag is lower than that of Eisai and Biogen's first Alzheimer's disease drug, Aduhelm, which was initially priced at $56,000 annually before the drugmakers halved the price amid controversy over its approval. Eisai and Biogen said on Saturday the Japanese drugmaker had applied for full approval by the U.S. Food and Drug Administration. Some analysts expect broader coverage by Medicare if the drug is granted full approval.

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