Leqembi could mark new era in Alzheimer’s treatment progress: An overview of the evolving drug development scene

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Today, the FDA granted traditional approved to lecanemab (branded as Leqembi), a monoclonal antibody from Eisai and Biogen for adult patients with Alzheimer’s disease. The agency made the decision on the basis of a confirmatory trial that showed its clinical benefit.

The drug, which reduces the formation of amyloid plaques in the brain, is the first of its kind to transition from an accelerated approval to a traditional approval for Alzheimer’s treatment.

Leqembi’s annual launch price is $26,500.

Following approval, lecanemab stands to potentially gain Medicare coverage with qualifications.

The approval of Leqembi is a positive step forward and will spur further advances and investments in Alzheimer’s research, according to Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation (ADDF).

“We final…

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CMS continues to restrict coverage of amyloid-targeting antibodies for Alzheimer’s

[Image courtesy of CMS]

CMS has denied the Alzheimer’s Association’s request asking for broader reimbursement support for FDA-approved monoclonal antibodies targeting amyloid.

In April 2022, CMS decided to limit coverage of such antibodies for Alzheimer’s to clinical trial volunteers. At that time, aducanumab from Biogen (Nasdaq: BIIB) and Eisai (TYO:4523) was the only FDA-approved antibody for the neurodegenerative condition.

CMS noted in an announcement that its latest decision rests on the current lack of evidence that amyloid-targeting antibodies are effective against Alzheimer’s.

Amyloid-targeting antibodies intend to treat Alzheimer’s by targeting and removing amyloid beta, a protein that accumulates in Alzheimer’s patients’ brains. The protein deposits eventually result in plaques that interfere with normal brain function.

Alzheimer’s organ…
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Eisai prepares to share more findings for Alzheimer’s antibody lecanemab

Tokyo-headquartered Eisai Co. is preparing to share efficacy, safety and biomarker findings from its Phase 3 confirmatory clinical study of the amyloid beta-protein inhibitor lecanemab.

The company will present full results from the Phase 3 confirmatory Clarity AD study of lecanemab in patients with early Alzheimer’s disease in a session at the Clinical Trials on Alzheimer’s Disease conference on November 29.

Eisai is jointly developing the antibody with Biogen (Nasdaq:BIIB).

Last week, Roche (SWX:ROG) that its Alzheimer’s hopeful gantenerumab flunked two Phase 3 studies, failing to meet the primary endpoints in either one.

Gantenerumab won breakthrough therapy designation from FDA in 2021.

In late September, Eisai and Biogen reported positive Phase 3 trial results for lecanemab, noting that the drug candidate met primary and key secondary endpoints. Lecanemab recipients had a 27% reduction in disease progression with a p-…

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Eisai unveils new facility for injectable drug formulation research

Eisai (OTCMKTS:ESALY) has announced that it has completed the construction of a new research building dedicated to the formulation of injectable drugs at the Kawashima Industrial Park located in Gifu Prefecture, Japan.

The Eisai Medicine Innovation Technology Solutions (EMITS) facility will serve as Eisai’s global headquarters for formulation and research.

Traditionally focusing on small molecules, Eisai has ramped up its focus on drug discovery targets to include antibodies, antibody-drug conjugates (ADCs) and nucleic acid drugs.

The EMITS facility will conduct research on injectable drug formulation and drug delivery systems. In particular, Eisai plans to explore liposomal and lipid nanoparticle formulations.

Eisai plans to use AI to enhance drug formulation.

It also aims to manufacture investigational injectable drugs at the facility for clinical trials and develop rapid microbial testing methods for microbiological control and ste…

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Eisai and Biogen report positive Phase 3 trial results for new Alzheimer’s drug

Eisai and Biogen (Nasdaq:BIIB) today announced positive topline data from a Phase 3 trial of lecanemab for Alzheimer’s disease.

BIIB shares are skyrocketing on the back of the data today. They are up 37.6% at $272.12 apiece in mid-afternoon trading.

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody. The global Phase 3 confirmatory Clarity AD clinical trial evaluated it for treating mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.

The drug met its primary endpoint and all key secondary endpoints with what the companies called “highly statistically significant results.” Eisai plans to discuss the data with regulatory authorities in the U.S., Japan and Europe. The company aims to file for traditional U.S. approval and authorization in Japan and Europe by the end of fiscal 2022 (March 31, 2023). Read more

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Nine out of ten U.S. neurologists have Aduhelm efficacy doubts

A recent physician survey found that 89% of neurologists in the U.S. have concerns about the efficacy of the controversial Alzheimer’s drug Aduhelm (aducanumab) from Biogen (Nasdaq:BIIB) and Eisai Co. (TYO:4523). Nearly as many — 87% — were concerned about the drug’s safety profile.

The survey from the physician social media network Sermo (New York City) asked more than 50 neurologists about their view of the drug, which has failed to find widespread use, generating just $3 million in 2021. Only 11% of the neurologists surveyed reported prescribing the drug.

Despite low uptake, many patients are aware of the drug. A total of 62% of the surveyed neurologists reported that at least one patient had asked them about Aduhelm.

The drug has faced an array of challenges since it was FDA-approved in June 2021. Recently, Medicare decided to limit Aduhelm’s coverage of the drug to clinical trial participants, and other payers, including the Department of Veteran Af…

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CMS will limit coverage of Aduhelm to people in clinical trials

The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab).

Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval and, about a week later, nonprofit watchdog group Public Citizen called for high-profile resignations for FDA officials as a result of the approval.

In August 2021, the HHS Office of Inspector General announced that it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug.

Get the full story at our sister site, Pharmaceutical Processing World.

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CMS will limit coverage of Aduhelm to people in clinical trials

The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab).

Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval and, about a week later, nonprofit watchdog group Public Citizen called for high-profile resignations for FDA officials as a result of the approval.

In August 2021, the HHS Office of Inspector General announced that it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug.

Yesterday’s CMS policy stated that Aduhelm and any future monoclonal antibodies directed against amyloid approved by the FDA will be covered by Medicare under coverage with evidence development (CED). CMS will, as part of the decision, provide enhanced acces…

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Eisai amends Aduhelm collaboration with Biogen

Aduhelm (aducanuamab) co-developer Eisai Co. (TYO:4523) has agreed to modify its economic partnership agreement with Biogen (Nasdaq:BIIB).

Starting January 1, 2023, Eisai will receive a tiered royalty on net sales of the Alzheimer’s disease therapy Aduhelm (aducanumab) rather than share profits or losses of the drug.

Eisai would receive between 2% and 8% of annual sales of the Aduhelm.

The Tokyo-based company also has given Biogen total decision-making power and commercialization rates globally for Aduhelm.

Analysts’ projections for Aduhelm have dimmed significantly in the wake of the drug’s approval by FDA in June 2021.

Eisai’s partnership with Biogen on the investigational Alzheimer’s drug lecanemab collaboration will remain unchanged globally. The two companies, however, have agreed to extend a supply agreement from five to 10 years that would have Biogen manufacture the drug candidate.

Lecanemab, lik…

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J&J and Roche named to Clarivate’s Top 100 Global Innovators list 

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

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Japan appears to eye Alzheimer’s drug Aduhelm with skepticism

Japan could follow the lead of the European Medicines Agency, which recommended refusing the marketing authorization of the controversial drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (Tokyo). 

Japan’s First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council recommended further discussion of the application for the drug. The NDC also requested additional information as it continues its decision-making process. 

The Japanese regulators voiced skepticism about clinical data correlating reductions in beta-amyloid with improvement in Alzheimer’s symptoms. 

Biogen said it would continue collaborating with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the matter.

Biogen plans on beginning a confirmatory trial for Aduhelm next year, which could conclude in 2026. 

Owing to weak demand for the drug in the U.S., Biogen announced that it was slashing the wholesale cost of the drug in hal…

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Biogen’s eyeing layoffs as Aduhelm sales sputter: Report

As Biogen (NSDQ:BIIB) continues to struggle to market the controversial drug Aduhelm (aducanumab), the company is eyeing up to 1,000 layoffs, according to a report from STAT.

Biogen did not immediately respond to a request for comment.

Following FDA approval of the drug in June, BIIB shares soared to a record high. However, its stock has fallen steadily since then. BIIB shares are now trading at $232.62, 4.25% down from the beginning of the year.

As of October, the drug had spurred $2 million in sales and only $300,000 of that sum was in the third quarter.

Biogen developed Aduhelm in concert with Eisai (TYO:4523).

Between June to present, Adhelm has faced several setbacks. The approval of the drug has attracted federal investigations. In August, the Department of Veterans Affairs (VA) decided not to include Aduhelm in its drug formulary. In November, the European Medicines Agency (EMA) gave the marketing authorization application for Aduhel…

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