An innovative Alzheimer’s drug, donanemab, has recently been granted unanimous approval by a panel of advisors from the Food and Drug Administration. Developed by Eli Lilly, this drug has demonstrated promising results in slowing down the progression of cognitive decline in individuals with early-stage Alzheimer’s disease.
Administered through infusion, donanemab works by targeting and removing amyloid plaque buildups believed to be a major factor in the development of Alzheimer’s. However, like other medications for Alzheimer’s treatment, donanemab may have side effects such as brain swelling and bleeding, as observed in a study spanning 76 weeks.
Despite the potential risks, individuals receiving donanemab experienced a delay in cognitive decline ranging from 4.5 to 7.5 months, as reported by Eli Lilly and noted in recent coverage by the New York Times. Based on the overall benefits outweighing the risks, the FDA advisory committee supported the approval of this drug.
This decision comes after a review process that was similar to the one undergone by Leqembi, a drug developed by Eisai and Biogen, which has comparable side effects to donanemab. Biogen was also behind Aduhelm, a controversial drug that was ultimately discontinued by the manufacturer.