Eisai to Likely Miss Patient Goal for Leqembi by End of March 2024

MRI Scans_iStock, Nur Ceren Demir

Pictured: MRI scans of the brain/iStock, Nur Ceren Demir

During Tuesday’s third-quarter fiscal year 2023 earnings report, Eisai revealed that the launch of its Biogen-partnered Alzheimer’s disease treatment Leqembi (lecanemab) has not been going according to plan, making the company’s goal of treating 10,000 patients by the end of March 2024 appear out of reach.

As of Jan. 26, 2024, Leqembi has been administered to 2,000 patients in the U.S., according to Eisai’s presentation on Tuesday, with around 8,000 more on a waiting list. However, on an investor call, Keisuke Naito, Eisai’s global Alzheimer’s disease officer, said that meeting the company’s target of treating 10,000 patients by the end of March 2024 would be “challenging.”

Still, the Japanese pharma expects the uptake of Leqembi to “increase rapidly” in the coming months driven by the therapy’s full approval and broader coverage of PET scans, according to Naito.

Eisai has also zeroed in on specific areas with “particularly large numbers of patients” waiting for their Leqembi treatment—including California, Florida and New York—and will allocate more of its resources to these markets.  

“Based upon our various activities to date, we believe that as the diagnosis and the treatment pathways are established and implemented smoothly … then we will be able to administer Leqembi to these patients,” Naito said.

Naito also added during the call that in the coming months and years, as it establishes triaging and confirmatory testing, Eisai will also be able to expand its Alzheimer’s business by offering maintenance Leqembi dosing as well as a subcutaneous formulation “to provide more convenience to patients.”

Developed by Eisai and Biogen, Leqembi is an anti-amyloid antibody that works by targeting and removing soluble toxic amyloid-beta clumps in the brain, which could lead to Alzheimer’s disease. Leqembi won the FDA’s accelerated approval in January 2023 and months later, in July 2023, it became the industry’s first-ever Alzheimer’s antibody to secure the regulator’s full approval.

The FDA’s full approval of Leqembi opened the therapy up for coverage from the Centers for Medicare and Medicaid Services (CMS) and in November 2023, Eisai reported that uptake of Leqembi had increased “dramatically.” A July 2023 proposal from CMS to broaden its coverage of PET scans to detect amyloid plaques in the brain also potentially helped bump up sales for Leqembi.

In the third quarter of fiscal year 2023, Leqembi brought in around $7.4 million, a significant increase from its approximately $2 million in sales during the second quarter. At its current pace, Leqembi is generating $1.5 million in sales per week, which puts the company on track to make about $20 million from January through March 2024, according to an analysis by BioPharma Dive.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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