USA — Eisai has unveiled a remarkable surge in Leqembi, its revolutionary Alzheimer’s disease therapy in its latest fiscal report.
The anti-amyloid antibody, gaining accelerated approval in January 2023, has seen a substantial rise in patient numbers following its conversion to full FDA approval in July of the same year.
The journey of Leqembi is marked by its accelerated approval in January 2023, swiftly followed by full FDA authorization after the promising outcomes of the Phase III Clarity-AD trial.
This significant milestone not only solidified the therapy’s standing but also paved the way for broader accessibility as it garnered coverage from the Centers for Medicare and Medicaid Services.
Eisai CEO Haruo Naito emphasized the impact, stating, “Compared to the level at the time of accelerated approval, the number of patients treated is increasing dramatically.” By October 27, around 800 Alzheimer’s disease patients had already received Leqembi in the U.S.
While Leqembi contributed approximately US$2.7 million in sales between April and September 2023, it represented a fraction of Eisai’s overall earnings.
Naito acknowledged market sentiments, recognizing voices of disappointment that may be influencing the company’s share price.
However, he reassured stakeholders, stating, “Please do not see this as a negative surprise,” pointing out that, in terms of weekly average revenue, Leqembi now stands 11 times higher than its pre-approval figures.
Eisai remains optimistic about Leqembi’s future, emphasizing its readiness for expansion. The number of specialists equipped to diagnose, treat, and monitor Alzheimer’s disease patients has surged from 1,400 to 2,500 between June and October 2023.
Moreover, Leqembi has gained approval from 60% of the top 100 Integrated Delivery Networks in the U.S.
The company has set an ambitious target of reaching approximately 10,000 patients by March 2024, aiming for a revenue of US$66 million.
Innovation on the horizon
To facilitate this growth, Eisai is venturing into a subcutaneous formulation of Leqembi. Presented at the 2023 Clinical Trials on Alzheimer’s Disease (CTAD) conference, data from the open-label extension phase of Clarity-AD showcased the advantages of a weekly subcutaneous injection over biweekly intravenous infusions.
However, caution is warranted, as safety issues, such as amyloid-related imaging abnormalities indicating potential bleeding and swelling in the brain, accompany this innovative approach.
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