Eisai, Biogen move closer to launching more convenient Alzheimer’s treatment

GLOBAL—Eisai and Biogen are one step closer to making their jointly developed Alzheimer’s treatment, Leqembi (lecanemab-irmb), more accessible to patients with a new, easier-to-use version.

The U.S. Food and Drug Administration (FDA) has accepted the companies’ biologics license application (BLA) for a subcutaneous form of Leqembi, which could simplify the treatment process for people with Alzheimer’s disease.

Currently, Leqembi is administered as an infusion every two weeks to patients with mild cognitive impairment or early-stage dementia.

 The new subcutaneous version, which involves a weekly autoinjector, would make it easier for patients and their caregivers to manage the therapy at home, reducing the need for hospital visits and long infusion sessions.

This version also allows for quicker, less intrusive weekly treatments after the initial biweekly intravenous doses.

The FDA has set August 31, 2025, as the target decision date for the new drug form under the Prescription Drug User Fee Act (PDUFA).

 Eisai and Biogen’s submission for the subcutaneous Leqembi is based on data from their Clarity AD trial, which showed promising results.

 In an open-label extension trial, the subcutaneous form of Leqembi reduced amyloid plaques in the brain by 14% more than the infused version in patients who had never received the drug before.

 Amyloid plaques are abnormal protein clusters in the brain that are believed to play a significant role in Alzheimer’s disease and are associated with memory loss and cognitive decline.

The companies initially planned to file their application in March 2024, but the FDA requested additional immunogenicity data, causing a delay.

The final submission began in May, and Eisai and Biogen are also awaiting approval for a monthly intravenous version of Leqembi, which has a PDUFA action date later this month.

Despite some setbacks, including slower-than-expected adoption in the U.S. due to logistical challenges and limited diagnosis access, Leqembi has shown strong potential.

In November 2024, Eisai revised its sales forecast, trimming its expected 2024 revenue from US$370 million to US$280 million due to slower uptake.

However, the drug still remains a leader in the Alzheimer’s treatment space.

Leqembi’s market dominance is expected to generate around US$5.3 billion in revenue by 2030, while Eli Lilly’s rival treatment, Kisunla (donanemab), which received FDA approval in July 2024, is projected to generate US$1.8 billion.

As Eisai focuses on expanding Leqembi’s dosing options, Biogen is working to strengthen its presence in the neuroscience field.

Just last week, Biogen proposed purchasing additional shares of Sage Therapeutics, a company in which it already holds a stake, as it continues to broaden its portfolio of treatments for neurological disorders.

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