Cassava Sciences Inc (SAVA)

[investingdog]

Copilot
The U.S. Food and Drug Administration (FDA) will convene an in-person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) on Monday, June 10, 2024, to discuss Donanemab. Eli Lilly and Company has submitted Donanemab for the treatment of early symptomatic Alzheimer’s disease. The Phase 3 study submitted as part of this application, TRAILBLAZER-ALZ 2, evaluated the safety and efficacy of Donanemab in participants aged 60-85 years with early symptomatic Alzheimer’s disease (mild cognitive impairment or mild dementia due to Alzheimer’s disease) who had confirmed Alzheimer’s disease neuropathology. The trial enrolled 1,736 participants across eight countries, selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by positron emission tomography (PET) imaging. Donanemab selectively targets existing amyloid plaques, potentially improving disease progression.