Eisai Announces Promising Results for Injectable Alzheimer’s Drug
Eisai, a pharmaceutical company, revealed that an injectable version of the Alzheimer’s drug Leqembi has shown encouraging initial results in a clinical trial. This development could potentially provide a new and more convenient option for administering antibody treatment for Alzheimer’s disease.
Concerns Regarding Side Effects
However, it is important to note that the injection did not lead to lower rates of brain swelling and bleeding, which are the most concerning side effects associated with Leqembi.
Leqembi: A Breakthrough in Alzheimer’s Treatment
Leqembi, developed by Eisai in collaboration with Biogen, is the first medication proven to slow the progression of Alzheimer’s in individuals at the early stages of the disease. In July, U.S. regulators approved an intravenous infusion version of Leqembi that requires administration twice monthly through the veins.
Seeking Approval for Subcutaneous Administration
Eisai and Biogen are now seeking approval for a subcutaneous version of the drug, which would involve injecting it under the skin. This method would allow patients or their caregivers to administer Leqembi at home, eliminating the need for frequent visits to an infusion center like a hospital.
Eisai and Biogen have announced their plan to submit an application for U.S. approval of subcutaneous Leqembi by the end of March.
Preliminary Results from Clinical Trial Extension
Eisai presented preliminary results from an extension of a late-stage trial that supported the approval of intravenous Leqembi at the Clinical Trials on Alzheimer’s Disease conference in Boston. This study evaluated the safety and effects of subcutaneous doses of Leqembi on a protein called amyloid, which is associated with Alzheimer’s disease.
The study demonstrated that two injections administered once weekly produced similar results after six months compared to the twice-monthly intravenous infusions in terms of safety, drug concentration in the blood, and the ability to clear plaque buildups in the brain.
Specifically, the injectable form of Leqembi removed 14% more plaque than the approved intravenous formulation, and blood concentration levels of the drug were 11% higher with subcutaneous Leqembi.
Concerns About Side Effects Persist
However, the newer form of the drug still exhibited side effects known as amyloid-related imaging abnormalities (ARIA), including brain swelling and bleeding. Approximately 17% of patients receiving weekly injections experienced ARIA-E, while only 13% of those receiving intravenous infusions had this side effect. Additionally, 22% of individuals receiving injections had ARIA-H, compared to 17% in the other group.
The Rising Impact of Alzheimer’s Disease
According to the Alzheimer’s Association, nearly 6.7 million Americans aged 65 and older are currently living with Alzheimer’s. This number is projected to reach almost 13 million by 2050.
The association highlights that one in three seniors die with Alzheimer’s or another form of dementia, making it the leading cause of death compared to breast cancer and prostate cancer combined. Alzheimer’s starts with mild memory loss and progressively impairs an individual’s cognitive abilities and daily functioning.
The Challenges in Alzheimer’s Treatment
Alzheimer’s research has been extensive, but finding effective treatments has proven to be extremely challenging. Many drugs developed to target the disease have failed in clinical trials. The high cost and lengthy research process further hinder drug development. Additionally, scientists have sparked a debate over the true cause of the disease and the appropriate targets for medication.