FDA Grants Approval for Leqembi IV Maintenance Dosing

New Approval for Leqembi's IV Maintenance Dosing

BioArctic AB (publ) is excited to announce a significant milestone in the treatment of Alzheimer’s disease. The U.S. Food and Drug Administration (FDA) has approved a new once every four weeks intravenous (IV) maintenance dosing for Leqembi (lecanemab-irmb), developed in partnership with Eisai. This new regimen offers an additional option for patients who have successfully completed the initial biweekly treatment phase of 18 months. The new dosing of 10 mg/kg provides a more convenient approach for those in the early stages of Alzheimer’s disease, specifically for individuals suffering from mild cognitive impairment (MCI) or mild dementia.

Understanding the Importance of Ongoing Treatment

Research indicates that ongoing treatment is crucial for managing Alzheimer's disease effectively. Previous studies have highlighted that discontinuing treatment can lead to the reaccumulation of toxic amyloid in the brain, resulting in a decline in cognitive function. In fact, data from the Phase 2 study demonstrated significant reductions in cognitive decline when patients continued treatment with Leqembi. The findings suggest that patients on the new maintenance regimen can expect to maintain clinical and biomarker benefits over time.

Leqembi's Mechanism of Action

Leqembi provides dual-action support in the fight against Alzheimer’s disease. It effectively clears amyloid-beta (A?) plaque from the brain, which is known to contribute to neurotoxicity. At the same time, it combats the progressive nature of the disease by continuously eliminating highly toxic protofibrils that can damage neuronal cells. This combined approach not only addresses existing neurotoxic factors but also helps in preventing further neurodegeneration, providing hope to patients and caregivers.

Data Supporting the New Dosing Regimen

The approval of the new IV maintenance dosing is supported by extensive modeling of data from Phase 2 studies, as well as findings from the Clarity AD study and its long-term extension. The simulations clearly predict that transitioning to a once every four weeks dosing schedule after the initial treatment phase will preserve the gains achieved through biweekly dosing, offering patients continued benefits.

Global Reach and Future Plans for Leqembi

Leqembi is not just limited to the U.S. market. The medication has already received regulatory approval in various countries, including Japan, Great Britain, and China. In recent developments, it has also gained a positive opinion from the European Medicines Agency, paving the way for additional approvals across Europe. Furthermore, Eisai is actively pursuing applications for Leqembi in numerous other regions, marking it as a globally recognized treatment option for Alzheimer’s disease.

The Collaboration Behind Leqembi

The success of Leqembi can be attributed to a long-standing collaboration between BioArctic and Eisai, dating back to 2005. The partnership has been crucial for the scientific advancements and commercialization efforts related to the drug. Eisai is tasked with the clinical development and market approvals, while BioArctic plays a vital role, particularly in the Nordic regions where they are preparing for joint commercialization as necessary approvals are secured.

About BioArctic's Vision

As a research-based biopharma company, BioArctic AB remains committed to innovating treatments that aim to delay or halt the progression of neurodegenerative diseases. Beyond Leqembi, the company continues to explore promising avenues in treating conditions such as Parkinson's disease and ALS, utilizing its cutting-edge BrainTransporter™ technology, which optimizes antibody efficacy in crossing the blood-brain barrier.

Company Contact Information

For further inquiries, please reach out to Oskar Bosson, VP of Communications and Investor Relations, via phone at +46 70 410 71 80.

Frequently Asked Questions

What is Leqembi used to treat?

Leqembi is primarily used for treating early Alzheimer's disease, specifically mild cognitive impairment (MCI) and mild dementia.

How often is the new IV dosing regimen for Leqembi?

The new IV maintenance dosing regimen for Leqembi is once every four weeks after the initial treatment period.

Why is ongoing treatment important for Alzheimer's disease?

Ongoing treatment helps to maintain cognitive function and prevents the reaccumulation of neurotoxic amyloid in the brain.

What is unique about Leqembi's mechanism of action?

Leqembi acts by not only clearing amyloid-beta plaque but also by eliminating toxic protofibrils that cause neuronal injury.

How long has BioArctic collaborated with Eisai?

BioArctic has been in collaboration with Eisai since 2005, focusing on the development and commercialization of treatments for Alzheimer's disease.

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