U.S. Veterans Gain Access to Alzheimer's Disease Treatment
Eisai Co., Ltd. today announced that the U.S. Veterans' Health Administration (VHA) is providing coverage of LEQEMBI™ to veterans living with early stages of Alzheimer's disease (AD).
As of March 13, 2023, VHA healthcare professionals meeting the criteria set forth by the VHA can prescribe LEQEMBI to veterans who fit the VHA's standards and the U.S. Food and Drug Administration's (FDA) current label.
The FDA-approved LEQEMBI under the accelerated approval pathway in January 2023, and was launched in the U.S. on January 18, 2023.
LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (Aβ),
Treatment with LEQEMBI should only be initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology, the population in which treatment was initiated in clinical trials.
After the first infusion, 38% of LEQEMBI-treated patients had transiently decreased lymphocyte counts to <0.9 x109/L compared to 2% on placebo, and 22% of LEQEMBI-treated patients had transiently increased neutrophil counts to >7.9 x109/L compared to 1% on placebo.
Furthermore, there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
LEQEMBI is not a vaccine but is therapeutically administered via infusion.
In the event of an infusion-related reaction, the infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Prophylactic treatment with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids prior to future infusions may be considered.
The FDA has not approved an Alzheimer's disease vaccine as of March 2023.