BioArctic AB and its long-time partner Eisai are taking a significant step toward making Alzheimer’s treatment less burdensome for patients and healthcare systems. Eisai has submitted a proposed Marketing Authorisation Variation (MAV) to the European Medicines Agency (EMA) that would allow lecanemab to be administered as a once-every-four-weeks intravenous (IV) maintenance infusion, rather than the current biweekly schedule.

If approved, the change would mark an important evolution in how one of the most closely watched Alzheimer’s therapies is delivered across Europe—potentially improving adherence while reducing strain on infusion centers.

What’s Changing in Lecanemab’s Dosing

Under the current EU approval, lecanemab is administered as an IV infusion every two weeks at 10 mg/kg. Eisai’s submission proposes a two-phase approach:

• Initial phase: Patients continue with the existing biweekly dosing for the first 18 months

• Maintenance phase: Patients transition to once-every-four-weeks IV infusions thereafter

The indication itself remains unchanged. In the EU, lecanemab is approved for patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease, specifically those who are ApoE ε4 non-carriers or heterozygotes, with confirmed amyloid pathology. Treatment is discontinued once patients progress to moderate Alzheimer’s disease.

The proposal reflects a broader industry trend: optimizing dosing regimens to balance clinical benefit with real-world practicality, particularly for chronic neurodegenerative conditions.

Why This Matters for Patients and Providers

While the clinical efficacy of Alzheimer’s therapies often dominates headlines, treatment logistics can be just as critical to long-term success. Biweekly IV infusions are resource-intensive—for patients, caregivers, and healthcare systems alike.

A monthly maintenance regimen could:

• Reduce hospital and clinic visits

• Ease caregiver burden

• Improve patient adherence over longer treatment durations

• Free up infusion capacity as demand for disease-modifying therapies grows

As Europe braces for a rapidly aging population, these operational considerations are becoming central to regulatory and payer discussions—not just clinical endpoints.

Lecanemab’s Scientific and Commercial Roots

Lecanemab is the product of a decades-long collaboration between BioArctic and Eisai, rooted in foundational academic research. The antibody was originally developed by BioArctic, building on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation associated with Alzheimer’s disease.

Eisai leads global clinical development, regulatory filings, and commercialization, while BioArctic retains the right to commercialize lecanemab in the Nordic region. The two companies are currently preparing for joint commercialization across Nordic markets, highlighting the regional importance of the therapy.

This division of responsibilities has allowed BioArctic to remain deeply involved in scientific innovation, while Eisai brings scale and regulatory experience to global markets—a partnership model increasingly common in high-risk, high-cost therapeutic areas like neurology.

Competitive and Regulatory Context

Lecanemab sits at the center of a rapidly evolving Alzheimer’s treatment landscape, where regulators are under pressure to balance patient access, safety, and health system sustainability. Any change that meaningfully reduces treatment burden without compromising outcomes is likely to be scrutinized closely—but also welcomed.

From a competitive standpoint, dosing flexibility could become a differentiator as more disease-modifying Alzheimer’s therapies move through late-stage trials. Regulators and payers are not just evaluating whether drugs work, but how feasibly they can be deployed at scale.

What Happens Next

The EMA will now review Eisai’s proposed variation. A positive opinion would allow lecanemab’s label to be updated across the EU, potentially setting a precedent for maintenance-phase dosing strategies in Alzheimer’s care.

For BioArctic, the submission reinforces the long-term value of its partnership with Eisai and strengthens the commercial outlook in Europe—particularly in the Nordic region, where joint commercialization plans are already underway.

As Alzheimer’s therapies move from clinical promise to real-world practice, decisions like this one may quietly shape how sustainable—and scalable—next-generation treatments ultimately become.

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