The FDA announced on its official website that the drug "donanemab-azbt" developed by Eli Lilly and Co has been approved for the treatment of early-stage Alzheimer's disease patients with mild cognitive impairment. Eli Lilly executives wrote that Kisunla exhibited very meaningful effects and patients urgently need this effective treatment plan.
On July 3, CALI finance reported (Editor: Hao Zhao) that on Tuesday (July 2) local time,(FDA) approved Eli Lilly's drug donanemab-azbt for the treatment of early-stage Alzheimer's disease patients with mild cognitive impairment, and the brand name is "Kisunla".
Eli Lilly said that patients are infused with Kisunla every four weeks, with a unit price of $695.65 per bottle, a six-month course costing $12,522, a 12-month course costing $32,000, and an 18-month course costing $48,696.
Source: Official Website of Eli Lilly and Company
It is understood that donanemab is a monoclonal antibody that targets beta-amyloid protein in the brains of Alzheimer's disease patients, and abnormal deposition of beta-amyloid protein in the brain is one of the main pathological features of Alzheimer's disease. Donanemab binds to a beta-amyloid protein subtype called N3pG, which can help patients complete plaque clearance.
A month ago, an 11-member independent expert panel convened by the FDA unanimously endorsed the effectiveness of donanemab in slowing the early progression of Alzheimer's disease, believing that its benefits outweighed its risks.
"Kisunla has shown a very meaningful effect, and patients urgently need this effective treatment plan," said Anne White, Executive Vice President and President of Eli Lilly Neuroscience, in a latest news release.
White added, "We know that these drugs will have their greatest potential impact if patients receive treatment early, and we are working with other companies to improve detection and diagnosis."
Ronald Petersen, a neurology expert at the well-known US medical institution Mayo Clinic International, said the approval was significant because it added another treatment option for this well-known disease. "This will provide new options for clinical doctors and patients."
A year ago, the FDA fully approved the first Alzheimer's disease drug, Leqembi, jointly developed by Japan's CMIC CMO and the US Biogen. Some analysts expect donanemab to be better than Leqembi because it has shown higher efficacy in trials.
In phase III trials, Leqembi slowed cognitive decline by 27% compared with the placebo group, while donanemab slowed cognitive decline by 35%. However, donanemab and similar drugs have safety issues related to brain swelling and hemorrhage, and three patients died due to brain swelling events.