What's Happening?
Eisai Co., Ltd. has initiated a rolling submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for LEQEMBI IQLIK, a subcutaneous autoinjector for the treatment of early Alzheimer's disease. This application follows the FDA's granting of Fast Track Status for the drug, which is intended for patients with Mild Cognitive Impairment or mild dementia. The subcutaneous formulation aims to offer a more convenient at-home treatment option compared to the existing bi-weekly intravenous dosing. The application is based on studies conducted during the Phase 3 Clarity AD open-label extension, which evaluated the subcutaneous administration of lecanemab across various doses.
Why It's Important?
The approval of LEQEMBI IQLIK as a subcutaneous treatment could significantly impact the management of Alzheimer's disease by providing patients and caregivers with a more accessible and less resource-intensive option. This development may reduce the need for healthcare resources associated with intravenous dosing, such as infusion preparation and nurse monitoring. The drug targets amyloid plaques and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's patients. If successful, this could enhance the quality of life for patients and potentially slow the progression of the disease.
What's Next?
Should the FDA approve the subcutaneous dosing regimen, LEQEMBI IQLIK could become the first anti-amyloid treatment available for at-home use from the start of treatment. This would offer patients a choice between intravenous and subcutaneous administration, potentially streamlining the Alzheimer's treatment pathway. Eisai and Biogen are co-commercializing the product, with Eisai leading the development and regulatory submissions globally.
