News

FDA approves new Kisunla dosing regimen to lower ARIA-E risk

The U.S. Food and Drug Administration (FDA) has approved a more gradual titration dosing schedule for Kisunla (donanemab) for people with early symptomatic Alzheimer’s disease based on evidence that it can lower the risk of ARIA-E, a potentially serious side effect characterized by brain swelling. While the total…

ApoE4 Alzheimer’s Alliance launched as US advocacy group

A new patient advocacy organization, the ApoE4 Alzheimer’s Alliance, has launched in the U.S., with a goal of helping advance both supportive policies and the development of treatments for people with Alzheimer’s disease associated with the ApoE4 gene variant. According to the National Institutes of Health, this variant…

Leqembi approved in EU as treatment for early Alzheimer’s

Leqembi (lecanemab) has won marketing authorization in the European Union for the treatment of certain adults with early Alzheimer’s disease, making it the first therapy that targets an underlying cause of the neurodegenerative condition to be approved in the region. The treatment is indicated for adults with mild…

Leqembi IV monthly maintenance dosing approved by FDA

The U.S. Food and Drug Administration (FDA) has approved monthly maintenance dosing for Leqembi (lecanemab), a treatment for early Alzheimer’s disease. The decision follows a supplemental application from Eisai, which is codeveloping Leqembi with Biogen, based on the modeling of data from the Phase…