WESTON (dpa-AFX) - Drug makers Biogen Inc. (BIIB) and Japan's Eisai Co., Ltd. (ESALY.PK, 4523.T, EII.SG) announced Wednesday that Japan has approved LEQEMBI Pen, the subcutaneous (SC) formulation of the anti-amyloid beta (A?) protofibril antibody LEQEMBI (lecanemab), as a new route of administration for early Alzheimer's disease or AD.
The companies noted that the pen is the first and only anti-Amyloid treatment in Japan that enable at-home administration for AD, a progressive, relentless disease.
LEQEMBI Pen is an autoinjector formulation, which enables administration by a care partner or patient self-administration, with two pens totaling 500 mg administered once weekly.
The approval in Japan is based on the integrated results of data and associated modeling and simulation from the 18-month core study of the Phase 3 Clarity AD study of LEQEMBI in patients with mild cognitive impairment (MCI) due to AD or mild AD dementia, as well as multiple SC administration sub-studies in its subsequent long-term extension study.
Japan is the third country globally to approve LEQEMBI SC formulation. With the latest 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.
According to the companies, LEQEMBI Pen may reduce the time required for anti-amyloid therapy administration compared with IV infusions. In addition, at-home administration may reduce the burden of clinic visits for patients and their care partners and provide greater flexibility in treatment.
Eisai is the lead for lecanemab's development and regulatory submissions globally, with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
In Japan, Eisai shares closed Wednesday's regular trading at 4,788.00 yen, up 0.44 percent.
In the after-hours trading on Nasdaq, Biogen shares gained 0.01 percent, at $216.19, after losing 0.55 percent on Tuesdar's regular trading close.
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