- In December 2024, Eisai Co., Ltd. and Biogen Inc. announced that Mexico's Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) has approved LEQEMBI (lecanemab), a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, for the treatment of early Alzheimer’s disease (AD)
- In July 2024, the U.S. Food and Drug Administration (FDA) granted approval for Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), an Alzheimer’s treatment by Eli Lilly and Company. This approval is for adults with early symptomatic Alzheimer's disease (AD), including those with mild cognitive impairment (MCI) and individuals in the mild dementia stage of AD, who have confirmed amyloid pathology
- In July 2024, Alpha Cognition announced that the U.S. Food and Drug Administration (FDA) has approved ZUNVEYL (benzgalantamine), formerly known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer's disease. ZUNVEYL features a dual mechanism of action designed to prevent drug absorption in the gastrointestinal tract, potentially addressing tolerability issues associated with leading Alzheimer's medications, while offering the efficacy and long-term benefits of galantamine
- In January 2024, Biogen Inc. revealed its plans to refocus its resources on Alzheimer’s disease (AD), a key therapeutic area projected to drive both short-term and long-term growth. The company will continue to progress LEQEMBI (lecanemab-irmb), the first anti-amyloid beta treatment to receive FDA traditional approval in the U.S., and will expedite the development of potential new treatment options, such as its ASO targeting tau (BIIB080) and an oral small molecule inhibitor for tau aggregation (BIIB113)
- In May 2023, Eli Lilly and Company announced positive results from the TRAILBLAZER-ALZ 2 Phase 3 study, demonstrating that donanemab significantly slowed cognitive and functional decline in individuals with early symptomatic Alzheimer's disease. Donanemab successfully met the primary endpoint of change from baseline to 18 months on the integrated Alzheimer's Disease Rating Scale (iADRS)
- In January 2023, the U.S. Food and Drug Administration granted Accelerated Approval for Leqembi (lecanemab-irmb) as a treatment for Alzheimer's disease. Leqembi is the second medication in a new class designed to target the underlying pathophysiology of Alzheimer's disease
