FDA Approves Lilly’s Donanemab for Alzheimer’s Treatment Amid Manufacturing Concerns

1. FDA Approval: The Food and Drug Administration (FDA) has approved Eli Lilly's donanemab, an amyloid-targeting drug, for the treatment of early symptomatic Alzheimer's disease.
2. Mechanism of Action: Donanemab works by clearing amyloid beta, a sticky plaque in the brain linked to Alzheimer's, from the brain.
3. Clinical Trials: Recent clinical trials showed that donanemab reduced cognitive and functional deterioration in individuals with mild cognitive impairment by 35% over 18 months.
4. Safety Concerns: The drug carries a safety warning for the risk of amyloid-related imaging abnormalities (ARIA), which can lead to brain bleeding and swelling.
5. Pricing: Lilly will charge approximately $700 per vial, which translates to about $32,000 annually if treatment continues for a year.
6. Dosing Strategy: The FDA's label allows for treatment to be stopped if tests show the drug successfully clears amyloid from patients' brains, potentially making it less expensive for some patients.
7. Manufacturing Issues: Despite the approval, manufacturing issues were highlighted, which could impact the drug's availability.
8. Market Impact: The approval is expected to benefit the market for similar drugs, such as Leqembi, and could lead to increased adoption of amyloid-targeting treatments.