ALZHEIMERS DRUGS MARKET ANALYSIS

Key Developments

• In July 2024, the U.S. FDA approved Eli Lilly's new Alzheimer's drug, Kisunla (donanemab), for adults with mild cognitive impairment or early Alzheimer’s disease. Kisunla, a monoclonal antibody infusion administered every four weeks, targets amyloid plaques in the brain to modestly slow cognitive decline.
• In July 2024, the Alzheimer’s Association received the USFDA's approval  for Kisunla (donanemab, from Eli Lilly) for treating individuals with early symptomatic Alzheimer's disease. This includes those with mild cognitive impairment and mild dementia stages, provided they have confirmed amyloid plaques.
• In January 2024, Biogen Inc. refocused its resources on Alzheimer’s disease, emphasizing the development of LEQEMBI (lecanemab-irmb) and accelerating new treatments like BIIB080 and BIIB113. The company will discontinue ADUHELM (aducanumab-avwa) and end the ENVISION clinical study, reallocating the resources to its Alzheimer’s drug development.
• In June 2023, Centers for Medicare & Medicaid Services, CMS Administrator Chiquita Brooks-LaSure announced that Medicare will cover Alzheimer’s drugs that slow disease progression if these receive traditional FDA approval, provided these are used in settings that also gather real-world data on their effectiveness for Medicare beneficiaries