Eli Lilly's Alzheimer’s Drug Kisunla (Donanemab) Receives FDA Approval, Set to Challenge Biogen’s Leqembi in Key Therapeutic Arena

Intelligent Finance News learned that "donanemab-azbt," a drug developed by Eli Lilly and Company (LLY.US), has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of early-stage Alzheimer's disease patients with mild cognitive impairment, under the brand name "Kisunla." According to data from the Alzheimer's Association, nearly 7 million Americans suffer from this disease, which is the fifth leading cause of death for people aged 65 and older in the United States. By 2050, this population in the U.S. is expected to grow to nearly 13 million.

This is a long-awaited victory for Eli Lilly, after donanemab encountered obstacles on its path to market entry. Due to insufficient data, the FDA rejected the drug's approval last year, and then surprisingly delayed the approval again in March. Last month, an advisory panel of the agency recommended full approval of the therapy, stating that its benefits outweigh the risks.

Eli Lilly stated that patients will receive an intravenous infusion of Kisunla once every four weeks, with each vial priced at $695.65. The cost for a 6-month course of treatment is $12,522, for a 12-month course it is $32,000, and for an 18-month course, it is $48,696. Eli Lilly also mentioned that eligible patients may receive coverage and reimbursement through health insurance.

"Two Giants Compete" in the Alzheimer's Disease Treatment Field

Donanemab will compete head-to-head with another treatment drug, Leqembi, from Biogen (BIIB.US) and its Japanese partner Eisai. Leqembi has been gradually rolled out in the United States since its approval last summer.

"This is real progress. Today's approval allows people to have more choices and more opportunities, and more time. Having multiple treatment options is the progress we've all been waiting for," said Joanne Pike, president and CEO of the Alzheimer's Association.

Donanemab and Leqembi are milestones in the treatment of Alzheimer's disease. For the past three decades, efforts to develop drugs to combat this fatal disease have failed. Both drugs target beta-amyloid protein in the brains of Alzheimer's patients, and the abnormal deposition of beta-amyloid protein in the brain is one of the main pathological features of Alzheimer's disease, which can slow the progression of the disease in early-stage patients. Some analysts predict that donanemab may be superior to Leqembi due to its higher efficacy demonstrated in trials.

Donanemab binds to a β-amyloid protein subtype known as N3pG, which can help patients achieve plaque clearance. In Phase 3 trials, compared to the placebo group, Leqembi slowed cognitive decline by 27%, while donanemab slowed cognitive decline by 35% over 18 months. After reaching specific targets for amyloid plaque clearance, patients may discontinue treatment after 6, 12, or 18 months and switch to a placebo.

But neither treatment can cure. Drugs targeting and clearing amyloid plaques also carry significant safety risks, including brain swelling and bleeding, which in some cases can be severe or even fatal. In a late-stage trial, three patients taking Eli Lilly's drug died from serious side effects known as Amyloid-Related Imaging Abnormalities (ARIA).

Eli Lilly's drug is the third of its kind to enter the market, following Biogen and Eisai's Leqembi and Aduhelm. These two companies recently abandoned Aduhelm. The FDA was criticized for accelerating the approval of Aduhelm in 2021, despite negative recommendations from the advisory panel.