The U.S. Food and Drug Administration (FDA) advisory committee will discuss Eli Lilly’s Donanemab for Alzheimer’s treatment on June 10th.
Eli Lilly’s Donanemab is developed to eliminate the toxic Alzheimer ‘s-related protein beta-amyloid accumulated in the brain and is administered once a month via injection.
Donanemab was denied accelerated approval by the FDA in January last year and delayed when they received a notice from the FDA on March 8th of the same year to form an advisory committee to discuss Donanemab.
The independent advisory committee discussed Donanemab and LEQEMBI from Eisai and partner Biogen. However, while Donanemab’s approval has been delayed twice in the U.S., LEQEMBI, a drug similar to Donanemab, received FDA approval last year.
Clinical trial results showed that Donanemab treatment could delay the progression of memory and cognitive decline caused by Alzheimer’s disease by 22% to 29%, which is considered comparable to LEQEMBI’s 27% detain effect.
Furthermore, Donanemab showed that it could delay the progression of the disease in patients with mild to moderate levels of the second Alzheimer ‘s-related protein, Tau, by up to 35.1%.
However, experts predict that the approval process will not go smoothly due to the risk of brain edema and bleeding side effects associated with Donanemab.
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