US FDA approves Leqembi® IQKLIK ™ (lecanemab-irmb) subcutaneous injection for maintenance dosing for the treatment of early Alzheimer's disease

FDA Approval of Lecanemab Autoinjector

• Approval Announcement: BioArctic AB's partner, Eisai, announced that the U.S. FDA has approved the Biologics License Application for the once-weekly lecanemab subcutaneous injection, branded as LEQEMBI IQLIK, for maintenance dosing in Alzheimer's disease patients.
• Launch Date: The LEQEMBI IQLIK autoinjector is set to be launched on October 6, 2025.

Treatment Details

• Indication: LEQEMBI IQLIK is indicated for patients with mild cognitive impairment (MCI) or mild dementia, collectively referred to as early Alzheimer's disease (AD).
• Dosing Options: After 18 months of intravenous treatment, patients can choose between continuing with IV infusions or switching to the new weekly 360 mg subcutaneous injection.

Significance of Lecanemab

• Mechanism of Action: Lecanemab targets both amyloid plaque and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease.
• Unmet Need: There is a significant demand for new treatments that can slow the progression of Alzheimer's disease and alleviate the burden on patients and caregivers.

Patient and Healthcare Benefits

• Home Administration: The autoinjector allows patients to administer treatment at home, reducing the need for visits to infusion centers.
• Resource Efficiency: The subcutaneous formulation is expected to decrease healthcare resources required for IV maintenance, such as preparation and monitoring, while increasing capacity for new patients.

Collaboration Background

• Partnership: The development of lecanemab is a result of a long-term collaboration between BioArctic and Eisai, with BioArctic holding commercialization rights in the Nordic region.
• Financial Structure: BioArctic incurs no development costs for lecanemab and is entitled to regulatory approval payments, sales milestones, and royalties on global sales.

Broader Context

• Global Approval: Lecanemab is approved in 48 countries, including the U.S., Japan, China, and the EU, for treating early Alzheimer's disease and is under review in 10 additional countries.
• Ongoing Studies: Eisai's Phase 3 clinical study (AHEAD 3-45) is ongoing, focusing on individuals with preclinical Alzheimer's disease, and aims to further establish the efficacy of lecanemab.

Company Overview

• BioArctic's Focus: BioArctic AB is a Swedish biopharma company dedicated to innovative treatments for neurodegenerative diseases, with a portfolio that includes projects targeting Alzheimer's, Parkinson's disease, and ALS.
• Market Presence: BioArctic's shares are listed on Nasdaq Stockholm Large Cap, and the company is recognized for developing the first drug proven to slow Alzheimer's disease progression.