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☆ 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.

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.

☆ Here's where to look for the next developments in the fight against Alzheimer's disease
▼ + stars: | 2023-01-17 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +10 min

The Centers for Disease Control and Prevention estimates 5.8 million Americans were living with the disease in 2020 . BIIB 6M mountain Biogen's stock is trading well above its lows Leqembi treats Alzheimer's disease by targeting amyloid-beta plaques in the brain. Attention shifts to Eli Lilly Shares of other Alzheimer's drug developers have often mirrored Biogen's moves. Small drug developers Smaller Alzheimer's drug developers have also been boosted by research developments. Still in an early stage of its research, Prothena has traded as a proxy for developments in Alzheimer's treatment.

☆ Eli Lilly has spent years and billions of dollars in search of an effective Alzheimer's drug. But success is not all or nothing for the stock
▼ + stars: | 2023-01-09 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +22 min

Eli Lilly (LLY) has spent decades researching Alzheimer's disease without successfully bringing to market a treatment that slows the memory-destroying condition. For Eli Lilly as a company, an Alzheimer's drug is an important pursuit. Lilly's Alzheimer's history Eli Lilly's "first real foray" into Alzheimer's came in the 1990s, according to Dr. John Sims, Eli Lilly's head of medical development for donanemab. Financial implications for Lilly LLY mountain 2021-10-08 The Club started a new position in Eli Lilly (LLY) in October 2021. The Eli Lilly logo is shown on one of the company's offices in San Diego, California, September 17, 2020.

☆ Most Alzheimer’s patients would pay up to $26,500 per year for new treatment Leqembi
▼ + stars: | 2023-01-09 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

Few seniors with early Alzheimer's disease will have access to the new treatment Leqembi due to its high cost and very limited coverage by Medicare. "Even with Medicare coverage, beneficiaries would still be responsible for 20% coinsurance, and that's not a trivial amount." An investigation by lawmakers in the House concluded that the FDA approval process for Aduhelm was "rife with irregularities." "It's not going to be widely available even to people who are potentially eligible based on whether or not they have mild cognitive impairment related to Alzheimer's disease," Neuman said. CMS plans to provide broader coverage for Leqembi if the treatment receives full FDA approval under the traditional process, according to an agency statement.

☆ The FDA just approved a new Alzheimer's drug that's set to be a blockbuster
▼ + stars: | 2023-01-06 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +6 min

The FDA just approved a new treatment for Alzheimer's disease from Eisai and Biogen. Alzheimer's disease affects roughly 6.5 million Americans and has no cure. The FDA granted an accelerated approval of the drug, meaning the companies will have to conduct additional follow-up studies. While the drug has been approved, questions about cost remainWhile Leqembi has been approved by the FDA, the drug will have to face other key hurdles before it becomes widely available to patients. Aduhelm, an Alzheimer's drug also developed by Biogen and Eisai and approved by the FDA in 2021, failed to garner support from the Centers for Medicare and Medicaid Services, even after it was approved by the FDA.

☆ 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.

☆ We believe the risk-benefit profile for our Alzheimer's drug is acceptable, says Eisai U.S. CEO
▼ + stars: | 2022-11-30 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailWe believe the risk-benefit profile for our Alzheimer's drug is acceptable, says Eisai U.S. CEOIvan Cheung, Eisai U.S. CEO, joins 'Closing Bell' to discuss the results of Eisai's experimental Alzheimer's phase three trial, the side effects associated with the Alzheimer's drug and more.

☆ What increasing confidence in Biogen's latest Alzheimer's drug means for Eli Lilly
▼ + stars: | 2022-11-30 | by ( ) www.cnbc.com time to read: +6 min

Donanemab is the name of Eli Lilly's Alzheimer's drug in its own late-stage trials. JPMorgan has a neutral (hold) rating on Biogen shares and an overweight (buy) rating on Eli Lilly shares. What it means for Eli Lilly Eli Lilly has a phase three trial underway for its donanemab Alzheimer's drug that is similar to lecanemab, which is why the Biogen-Eisai data has been interpreted as favorable for the Club holding. Clumps of the protein, known as amyloid plaques, are one of the key markers of Alzheimer's disease. Previous drugs developed around the a-beta hypothesis — including those from Eli Lilly — have failed to meaningfully delay the disease's progression.

☆ Stocks making the biggest moves midday: CrowdStrike, Horizon Therapeutics, Petco and more
▼ + stars: | 2022-11-30 | by ( Tanaya Macheel | ) www.cnbc.com time to read: +3 min

Otherwise, CrowdStrike beat estimates on the top and bottom lines in its most recent quarterly results. Petco — Shares of Petco jumped 12% after reporting third-quarter revenue that was slightly above Wall Street estimates. Workday — Shares of Workday jumped 12% after the company posted earnings results Tuesday that beat Wall Street expectations. Though earnings beat Wall Street estimates, revenue came up short. Biogen — Shares rose more than 3% after a new study on Biogen and Eisai's experimental Alzheimer's drug showed promising results.

☆ Eisai shares plunge 10% in Tokyo after report of death in Alzheimer's trial
▼ + stars: | 2022-11-29 | by ( ) www.reuters.com time to read: +1 min

TOKYO, Nov 29 (Reuters) - Shares in Japanese drugmaker Eisai Co (4523.T) headed for their biggest plunge in more than a year on Tuesday after a report that a woman in a trial of the company's Alzheimer's disease treatment died. Eisai's shares sank 10% to 8,595 yen, leading decliners on the benchmark Nikkei index (.N225), which slid 0.5% in the morning session. Shares in Biogen sank 4.3% on Monday. Eisai and Biogen shares have been on a roller coaster in recent years on prospects for their candidates to battle dementia. Lecanemab was shown to slow cognitive and functional decline in a large trial of patients in the early stages of Alzheimer's disease, Eisai and Biogen said in September.

☆ Alzheimer’s Drug Slows Disease Progression in Trial
▼ + stars: | 2022-09-28 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

Eisai's headquarters in Nutley, N.J.; the company said it would present more detailed study results in November at an Alzheimer’s research conference. Eisai Co. and Biogen Inc. said their experimental Alzheimer’s disease drug significantly slowed progression of the memory-robbing disease in a large study, bolstering the drug’s prospects for approval. The pharmaceutical companies said their drug lecanemab reduced cognitive and functional decline by 27%, compared with a placebo, over 18 months in a Phase 3 study of 1,800 patients with early-stage Alzheimer’s. The drug was also linked to higher rates of brain swelling and small bleeds, though the company said they were rarely symptomatic.

☆ Biogen and Eisai's latest clinical trial just crossed the finish line. Here's why analysts say the results could disrupt the future of Alzheimer's care.
▼ + stars: | 2022-09-28 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +7 min

It's a complicated, debilitating illness and drug companies have struggled for years to come up with viable treatments. On Tuesday September 27, Biogen and Eisai announced that lecanemab slowed the rate of cognitive decline in Alzheimer's patients by 27%. Analysts say that this positive result could lead to it becoming a blockbuster drug for the companies. Other big drug companies such as Roche Holdings and Eli Lilly are pursuing similar treatments, with results expected to come later this year and early next year, respectively. "I think people's confidence in the amyloid hypothesis would go down even further, but ultimately people would wait to see what those other data events show," he said.

The trial results released on late Tuesday could mark a rare victory in the search for a treatment for the memory-robbing disease after years of clinical failures. Biogen's stock surged 46.6% to $290.99 in premarket trading, putting it on track to add over $13.5 billion in market capitalization. BMO analyst Evan Seigerman called the data an "unequivocal win" for Biogen and Alzheimer's patients. The latest trial boost for Biogen and Eisai's lecanemab has raised hope for success in trials testing Roche's gantenerumab and Lilly's donanemab. Shares of smaller Alzheimer's drug developers also rose in premarket U.S. trading.

☆ Eisai's Alzheimer's drug reduces cognitive decline by 27% in trial patients
▼ + stars: | 2022-09-28 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailEisai's Alzheimer's drug reduces cognitive decline by 27% in trial patientsEisai Co. Chairman and CEO for the U.S. Ivan Cheung joins 'Closing Bell' to discuss promising results from the company's latest drug trial for Alzheimer's, and the anticipated cost of the drug if it becomes publicly available.

☆ The success of Biogen's new Alzheimer's drug could be the start of a redemption arc for the biotech — and boost rivals racing to develop similar treatments
▼ + stars: | 2022-09-28 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +3 min

Biotech companies Biogen and Eisai just released data on their new Alzheimer's drug. Initial results of a highly anticipated test of an Alzheimer's drug, called lecanemab, were released on Tuesday evening by biotech firms Biogen and Eisai. "While the market has been skeptical of lecanemab's prospects, the trial appears to be a resounding success," Cowen analysts said. An earlier Alzheimer's drug developed by Biogen and Eisai, Aduhelm, also acts on beta-amyloid. Mizhuo analyst Graig Suvannavejh, said that the lecanemab results are "a key potential positive catalyst for companies" working to develop Alzheimer's treatments.

☆ 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.

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.

☆ Biogen's latest clinical trial is inching towards the finish line. Here's why analysts say the results could disrupt the future of Alzheimer's care.
▼ + stars: | 2022-09-19 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +7 min

It's a complicated, debilitating illness and drug companies have struggled for years to come up with viable treatments. Other big drug companies such as Roche Holdings and Eli Lilly are pursuing similar treatments, with results expected to come later this year and early next year, respectively. "I think people's confidence in the amyloid hypothesis would go down even further, but ultimately people would wait to see what those other data events show," he said. Negative results might give a boost to companies that are exploring alternate ways to treat Alzheimer's disease. And though Biogen's drug is furthest along in development, it's far from being the only treatment being tested for Alzheimer's.

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