Leqembi: A Paradigm Shift in Alzheimer’s Treatment—Assessing Commercial Scalability and Long-Term Profitability

The Alzheimer’s disease (AD) treatment landscape is undergoing a seismic shift with the advent of Eisai and Biogen’s Leqembi (lecanemab), a groundbreaking anti-amyloid therapy. Approved by the U.S. FDA in July 2023 and recently expanded to include a subcutaneous autoinjector formulation for maintenance dosing [1], Leqembi represents a critical step toward addressing the underlying pathology of AD. However, its commercial scalability and long-term profitability hinge on navigating complex regulatory, reimbursement, and safety challenges.

Regulatory and Reimbursement Hurdles: A Double-Edged Sword

Leqembi’s regulatory journey has been marked by cautious optimism. In the U.S., the FDA’s approval of the subcutaneous autoinjector in August 2025—a first for at-home administration in early AD—addresses a key barrier to patient adherence [1]. This formulation, which requires only 15 seconds of administration time, reduces the burden of frequent IV infusions and hospital visits [2]. However, the FDA’s recent safety communication mandating earlier MRI monitoring for amyloid-related imaging abnormalities (ARIA-E) underscores the need for rigorous risk management [3].

In the EU, the European Commission’s April 2025 approval of Leqembi for ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology reflects a narrower indication compared to the U.S. [6]. While this restricted label ensures patient safety, it limits market access. Controlled access programs (CAPs) in Austria and Germany, where Leqembi launched in August and September 2025, respectively, further constrain adoption by requiring physician registries and stringent monitoring [1]. These measures, while prudent, create friction in scaling the drug’s reach.

Reimbursement remains a critical wildcard. In the U.S., Medicare coverage is available for IV Leqembi under strict criteria, including amyloid confirmation and participation in a qualifying registry [5]. Eisai’s patient support programs, including co-pay assistance and the Patient Assistance Program (PAP), aim to mitigate financial barriers [1]. However, the drug’s annual cost of $26,500 for IV formulation—$26,632 for a 165-pound patient—poses a challenge for broader adoption [1]. The subcutaneous formulation, projected to save $18,223 per patient annually through reduced administration costs, could alleviate this pressure [2].

Market Adoption and Competitive Dynamics

Leqembi’s clinical differentiation—its ability to slow cognitive decline by 31% in the Clarity AD trial—has driven early adoption. In the U.S., real-world data from a two-year study showed 87.4% of patients remained on treatment, with 83.6% stabilizing or improving from mild dementia to mild cognitive impairment [1]. Global sales reached $87 million in Q4 2024, with U.S. sales accounting for $50 million [4]. These figures suggest growing confidence in Leqembi’s efficacy, even as safety concerns persist.

In the EU, Eisai and Biogen face a fragmented reimbursement landscape. Germany’s IQWiG and France’s HAS are demanding real-world evidence to justify cost-effectiveness [5], while other countries may adopt similar scrutiny. The EU’s CAPs, though necessary for safety, risk delaying widespread access. Eisai’s strategy to generate real-world data and expand blood-based biomarker use—27.5% of U.S. patients now use these diagnostics—could strengthen its case for broader approval [1].

Competitively, Leqembi faces rivals like Biogen’s aducanumab and emerging therapies targeting tau pathology. However, its unique mechanism of action—clearing amyloid-beta plaques—positions it as a first-line treatment for early AD. The subcutaneous autoinjector further enhances its appeal by reducing healthcare system strain [5].

Long-Term Profitability: Balancing Innovation and Risk

The long-term profitability of Leqembi depends on three factors: 1) scaling access through simplified administration, 2) securing favorable reimbursement terms, and 3) mitigating safety risks. The subcutaneous autoinjector, set to launch in the U.S. in October 2025, addresses the first challenge by enabling home use [1]. Eisai’s PAP and co-pay support programs aim to reduce financial barriers, but broader Medicare coverage for the subcutaneous formulation remains uncertain [5].

The second factor—reimbursement—requires navigating diverse EU healthcare systems. Eisai’s collaboration with local authorities to implement CAPs is a pragmatic approach, but pricing negotiations will be pivotal. In the U.S., the drug’s high cost could deter adoption unless payers recognize its long-term value in delaying institutional care costs.

The third factor—safety—demands continuous monitoring. ARIA-E, a known side effect involving brain swelling, necessitates early MRI surveillance [3]. While this adds to treatment costs, it also reinforces Leqembi’s role as a precision therapy, aligning with the shift toward personalized medicine.

Conclusion: A Transformative Therapy with Scalability Challenges

Leqembi’s potential to redefine Alzheimer’s care is undeniable. Its ability to slow disease progression, combined with the convenience of subcutaneous administration, positions it as a cornerstone of early AD treatment. However, commercial scalability will require overcoming reimbursement hurdles, safety concerns, and regulatory fragmentation. For investors, the key question is whether Eisai and Biogen can balance innovation with accessibility, ensuring that Leqembi’s transformative promise translates into sustainable profitability.

Source:
[1] FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease, [https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembir-iqliktm-lecanemab-irmb-subcutaneous]
[2] A U.S. Cost Comparison Model | Neurology and Therapy, [https://link.springer.com/article/10.1007/s40120-025-00790-2]
[3] FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease taking Leqembi (lecanemab), [https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommend-additional-earlier-mri-monitoring-patients-alzheimers-disease-taking-leqembi-lecanemab]
[4] LEQEMBI Market Sales Reflect Growing Confidence in Disease-Modifying Alzheimer’s Treatments | DelveInsight, [https://www.globenewswire.com/news-release/2025/03/03/3035903/0/en/LEQEMBI-Market-Sales-Reflect-Growing-Confidence-in-Disease-Modifying-Alzheimer-s-Treatments-DelveInsight.html]
[5] Statement: Broader Medicare Coverage of Leqembi, [https://www.cms.gov/newsroom/press-releases/statement-broader-medicare-coverage-leqembi-available-following-fda-traditional-approval]