#USA #Stockholm #Eisai #Alzheimer's Disease #Leqembi IQKLIK

Eisai's Leqembi® IQKLIK™ Receives FDA Approval for Alzheimer's Maintenance Treatment

In a significant advancement for Alzheimer's care, the U.S. Food and Drug Administration (FDA) has granted approval to BioArctic's partner, Eisai, for the Leqembi® IQKLIK™ (lecanemab-irmb) subcutaneous injection. This approval is specifically for maintenance dosing in patients diagnosed with early Alzheimer's disease, encompassing those with mild cognitive impairment (MCI) or mild stages of dementia. The LEQEMBI IQKLIK autoinjector is set to become available in the U.S. starting October 6, 2025.

The newly approved subcutaneous injection allows for a more convenient administration option for patients who have previously received intravenous treatment. After an initial 18 months of receiving lecanemab via IV at a dose of 10 mg/kg every two weeks, patients can choose between continuing with IV infusions or switching to the weekly subcutaneous injection at a dose of 360 mg.

Eisai has characterized Alzheimer's disease as a progressive condition marked by the buildup of amyloid-beta (Aβ) and tau proteins in the brain. Due to its relentless nature, Alzheimer's poses substantial challenges not only to patients but also to their caregivers. With the new maintenance treatment, the goal is to slow cognitive decline further and help extend the time that patients can maintain their sense of self.

According to Gunilla Osswald, CEO of BioArctic, this breakthrough in treatment represents a commendable effort to simplify care procedures for patients while enhancing the efficiency of healthcare administration. The advantages of the IQKLIK device include enabling patients to self-administer the medication at home, thereby alleviating the need for frequent visits to infusion centers. This could potentially free up healthcare resources, making room for newly eligible patients to begin treatment.

In addition, Leqembi is the only drug proven to address Alzheimer's in two unique ways: it actively targets both amyloid plaques and protofibrils, which are believed to play a central role in the progression of the disease. Research indicates that addressing protofibrils may mitigate neuronal damage, reducing cognitive dysfunction associated with Alzheimer’s, thus making maintenance therapy crucial for patient care.

The approval of Leqembi stems from a fruitful partnership between BioArctic and Eisai. The development of the antibody was fostered by Professor Lars Lannfelt, who discovered the Arctic mutation in Alzheimer's disease. Eisai holds responsibility for clinical development and commercialization, while BioArctic manages the rights to market Leqembi in the Nordic countries.

As of now, lecanemab is approved in 48 countries, including major markets like the U.S., Japan, China, and the European Union. Furthermore, it is undergoing regulatory assessments in an additional 10 countries. The ongoing research into lecanemab includes studies focused on individuals with preclinical stages of the disease, with the hope of optimizing treatment strategies even before clinical symptoms emerge.

Looking Ahead

With these promising advancements, both BioArctic and Eisai are gearing up for the upcoming launch of the Leqembi IQKLIK in the U.S. This development aligns with the ongoing need for innovative treatment modalities capable of transforming the landscape of Alzheimer's disease management. As the medical community continues to battle this relentless ailment, the introduction of a user-friendly subcutaneous option plays a vital role in enhancing patient quality of life and potentially alleviating the immense societal burden posed by this degenerative condition.

For more information regarding the approval and the mechanism of action of Leqembi, stakeholders are encouraged to reach out to Oskar Bosson, Vice President of Communications at BioArctic.