About 60 to 70% of dementia worldwide is accounted for by Alzheimer's disease, and a new era is opening where treatments can be administered at home.
On the 29th of last month (local time), Biogen from the United States and Eisai from Japan announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous injection formulation of the Alzheimer's disease treatment 'Leqembi' (ingredient name lecanemab).
Leqembi is the first antibody treatment to remove the abnormal accumulation of amyloid beta proteins that cause Alzheimer's disease, developed jointly by Biogen and Eisai. It received accelerated FDA approval in January 2023, followed by full approval in July of the same year, and was subsequently authorized in the United States, Japan, and Korea. It was launched in Korea last November.
The currently available Leqembi is an intravenous (IV) formulation, but it has now been developed into a subcutaneous injection (SC) formulation, which has received approval. The SC product name is LEQEMBI® IQLIK™, and the company noted that it plans to launch it in the United States on October 6.
This allows Alzheimer's patients to conveniently administer the treatment at home without visiting medical facilities. It takes only 15 seconds to administer Leqembi IQLIK. The previous intravenous method took over an hour for a single administration, and patients had to visit specialized facilities in person.
However, the FDA approved Leqembi IQLIK for maintenance therapy, allowing it to be used only for patients who have been treated with Leqembi for more than a year and a half. Previously, treatment was administered via 10 mg/kg IV every two weeks, but patients can now maintain IV therapy at four-week intervals or switch to a 360 mg subcutaneous injection once a week. Biogen and Eisai plan to apply for expanded eligibility to include new patients in the future.
Biogen stated, 'Leqembi IQLIK can be used at home without visiting medical facilities,' adding that 'patient convenience will be greatly improved compared to intravenous treatment, expanding access to therapy.'
These companies are reportedly planning to apply for approval of the Leqembi SC formulation from Japanese regulatory authorities within this year. In Korea, they plan to conduct a phased review after consultations with domestic authorities, but considering the approval application and review process, it is estimated that subcutaneous treatment may not be available until at least 2027.