Berkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.
The Food and Drug Administration has pushed back its approval decision deadline for Eli Lilly’s experimental Alzheimer’s drug donanemab. Lilly applied to the FDA for approval of the drug in July, after late-stage clinical trial data showed it slowed the progression of Alzheimer’s by 29% after 18 months, compared to a placebo. The results were comparable to those seen with Leqembi, a similar Alzheimer’s drug approved by the FDA last year.
7 million Americans ages 65 and older were living with Alzheimer's in 2023, according to the Alzheimer's Association. All three of the drugs are monoclonal antibodies that work by targeting amyloid in the brain, considered a hallmark of Alzheimer’s disease. While the medications appear to modestly slow the disease in clinical trials, they have been hampered by concerns of potentially life-threatening side effects, including brain swelling and brain bleeding.
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