Eisai Co. and Biogen Inc. have announced today that LEQEMBI® Pen, the subcutaneous (SC) formulation of the anti-amyloid beta (Aβ) protofibril antibody “LEQEMBI®” has been approved in Japan as a new route of administration. This marks the third country globally to approve LEQEMBI SC formulation.
LEQEMBI Pen is an autoinjector formulation that enables administration by a care partner or patient self administration, with two pens (totaling 500 mg) administered once weekly.
With this approval, LEQEMBI treatment now offers a new option of once-weekly SC administration at home, in addition to intravenous (IV) administration every two weeks in a hospital setting. LEQEMBI Pen may reduce the time required for anti-amyloid therapy administration compared with IV infusions (approximate injection time of 15 seconds per injection).
In addition, at-home administration may reduce the burden of clinic visits for patients and their care partners and provide greater flexibility in treatment, allowing patients to make treatment choices that better fit their lifestyles, including fewer constraints on going out and traveling. The improved convenience and flexibility of treatment with LEQEMBI is expected to lower barriers to initiating and continuing treatment with LEQEMBI.
Furthermore, LEQEMBI Pen also has the potential to reduce healthcare resources associated with IV dosing, such as nurse monitoring, as well as maintaining infusion capacity. These features are expected to contribute to further streamlining the overall Alzheimer’s disease (AD) treatment pathway. For amyloid-related imaging abnormalities (ARIA) monitoring, as with IV administration, brain magnetic resonance imaging (MRI) is performed prior to initiating treatment and at specified time points after treatment initiation.
