Biogen and Eisai win Japanese approval for Leqembi injection pen

Biogen ($BIIB) and Eisai received Japanese approval for Leqembi Pen, a subcutaneous formulation of their treatment for early Alzheimer’s disease. The regimen uses two pens totaling 500 milligrams once weekly, offering an alternative to intravenous treatment every two weeks. The companies expect the format to reduce the burden of repeated hospital visits.

At-home administration still requires the product’s inclusion on the designated injectable-drug list, followed by appropriate physician assessment and patient or caregiver training. Initial dosing must occur under medical supervision. MRI monitoring for amyloid-related imaging abnormalities continues, as with intravenous treatment. The decision adds an administration option for an existing therapy; it does not establish a cure, remove safety monitoring or mean unsupervised home use is immediately available to every patient.

Sources:

• Biogen / Eisai — Japanese approval announcement