US FDA approves Alzheimer’s drug ‘Donanemab’… 2nd dementia drug

by times news cr

2024-07-04 07:31:29

FDA approves Eli Lilly’s ‘Kissunra’

ⓒNewsis

Eli Lilly’s Alzheimer’s treatment donanemab has received approval from the U.S. Food and Drug Administration (FDA).

According to Eli Lilly and foreign media outlets on the 3rd, the FDA gave final approval to donanemab on the 2nd. Donanemab is used for adult Alzheimer’s disease patients with early symptoms, including mild dementia.

It is administered as an intravenous injection once a month and is marketed under the name ‘Kisunla’.

“Kissunra showed very meaningful results in patients with early-onset Alzheimer’s disease,” said Anne White, M.D., senior vice president and president of Eli Lilly’s Neuroscience Division. “This drug has the greatest potential benefit when treated early in the disease.”

Alzheimer’s disease is the most common degenerative brain disease that causes dementia. The exact pathogenesis and cause of Alzheimer’s disease are unknown, but it is believed to be caused by abnormal proteins such as amyloid beta (Aβ) and hyperphosphorylated tau protein accumulating in the brain.

Donanemab is designed to remove toxic Alzheimer’s-related proteins called beta-amyloid from the brain. In a large phase 3 clinical trial with 1,736 people, the results of the Alzheimer’s Disease Rating Scale (iADRS) showed that it slowed cognitive decline by 35%. In the key secondary endpoint, the Clinical Dementia Rating-Score (CDR-SB), it slowed it down in 29% of all patients, which is slightly higher than the 27% seen with the competing drug, Biogen/Eisai’s ‘Rekembi’ (recanemab).

Cerebral edema, a known side effect of donanemab, occurred in 24% of the donanemab treatment group, and cerebral hemorrhage occurred in 31%. In the placebo group, about 14% showed cerebral hemorrhage. In addition, three participants died from side effects.

Donenemab’s approval makes it the second Alzheimer’s treatment to receive FDA approval, following Rekemvi. About 7 million people in the United States are thought to have Alzheimer’s disease. According to the Alzheimer’s Association, Alzheimer’s disease kills more people than prostate and breast cancer combined.

“This approval is another step forward in advancing the standard of care for people with Alzheimer’s disease,” said Dr. Howard Fillit, co-founder of the Alzheimer’s Drug Discovery Foundation (ADDF).

[서울=뉴시스]

Hot news right now

2024-07-04 07:31:29

You may also like

Leave a Comment