Eisai and Biogen have received approval in Japan for LEQEMBI Pen, a subcutaneous (SC) formulation of lecanemab, for the treatment of early Alzheimer’s disease (AD). 

Alzheimer’s disease (AD) is a progressive neurological disorder and the most common cause of dementia. It gradually affects memory, thinking, behaviour and the ability to perform everyday activities. The disease is associated with abnormal changes in the brain, including the build-up of amyloid-beta plaques and tau proteins, which can damage and eventually destroy nerve cells.

LEQEMBI Pen is an autoinjector designed for once-weekly administration. The approved regimen consists of two pens, providing a total dose of 500 mg each week. Depending on clinical suitability and regulatory requirements, administration can be carried out by a healthcare professional, care partner or patient under appropriate medical supervision.
The approval introduces a new route of administration for LEQEMBI, which is also available as an intravenous (IV) formulation.

The SC formulation provides an alternative to the existing IV treatment, which is administered once every two weeks in a healthcare setting. Each SC injection takes approximately 15 seconds, potentially reducing the time required for drug administration compared with an IV infusion.

The approval may also provide greater flexibility for patients and their care partners by reducing the frequency of hospital or clinic visits. At-home administration will be subject to Japan's reimbursement and prescribing requirements. Patients or their caregivers must receive appropriate training and be assessed by a physician before self-administration is considered.

Monitoring for amyloid-related imaging abnormalities (ARIA) remains part of treatment management. As with IV administration, brain magnetic resonance imaging (MRI) is required before treatment begins and at specified points during treatment.

The approval makes Japan the third country to approve the SC formulation of LEQEMBI. It is supported by data from the 18-month Phase 3 Clarity AD study and additional subcutaneous administration studies conducted during the long-term extension phase.

The Clarity AD study evaluated lecanemab in people with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia. Data from the studies, together with modelling and simulation analyses, showed that once-weekly SC administration at a 500 mg dose produced drug exposure similar to IV administration every two weeks.

The findings supported the use of the SC formulation as an alternative administration method to the IV formulation. The overall safety profile of SC administration was generally consistent with that of IV treatment. Systemic injection or infusion-related reactions were reported less frequently with SC administration, with an incidence of 1.4% among participants newly starting lecanemab through SC administration in the relevant clinical data.

Eisai leads the global development and regulatory activities for lecanemab, while Eisai and Biogen jointly commercialise and promote the treatment. Eisai retains final decision-making authority for the product.

 

Source: biogen.com

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