Eisai and Biogen Overcome Filing Hitch, Initiate FDA Submission for Subcutaneous Leqembi

1. Eisai and Biogen have commenced a rolling submission to the U.S. Food and Drug Administration (FDA) for their subcutaneous formulation of Leqembi (lecanemab), a monoclonal antibody for treating Alzheimer's disease.
2. The companies experienced a hitch in their initial filing but have since resolved the issue and are now moving forward with the submission process.
3. Leqembi is designed to target and remove amyloid beta, a protein that accumulates in the brains of Alzheimer's patients and is believed to contribute to neurodegeneration.
4. The subcutaneous formulation of Leqembi aims to provide a more convenient and less invasive administration method for patients, as compared to intravenous infusions.
5. Eisai and Biogen are seeking approval for Leqembi through a Biologics License Application (BLA), which is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
6. The companies have conducted extensive clinical trials to evaluate the safety and efficacy of Leqembi, with promising results indicating potential benefits for Alzheimer's patients.
7. If approved, Leqembi would become one of the few available treatments for Alzheimer's disease, a neurodegenerative disorder that currently affects millions of people worldwide.