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 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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