FDA Approves Eli Lilly's Alzheimer's Drug Kisunla

The U.S. Food and Drug Administration (FDA) has granted approval for a new treatment aimed at slowing early-stage Alzheimer’s disease, providing patients with an additional option for managing their condition. This newly approved drug, donanemab, is an antibody treatment developed by Eli Lilly and will be marketed under the brand name Kisunla.

The FDA's decision comes after the agency's external experts unanimously endorsed the use of donanemab, arguing that its benefits for early-stage Alzheimer’s patients outweighed the associated risks. Joanne Pike of the U.S.-based Alzheimer’s Association hailed this development as significant progress. She emphasized that having multiple treatment options is a crucial advancement for individuals affected by the devastating disease.

In addition to Kisunla, patients with early-stage Alzheimer’s in the U.S. have access to another treatment called lecanemab, produced by Eisai and Biogen and sold under the brand name Leqembi. Administered intravenously every two weeks, Leqembi has been available for some time and also aims to slow the progression of Alzheimer’s symptoms.

Clinical trials for donanemab showed promising results. In a large, late-stage trial, the drug was found to slow the decline of memory and cognitive abilities by 29% compared to a placebo. However, the treatment also had some significant side effects, including brain swelling in nearly 25% of patients and brain bleeding in almost 33%. Despite these side effects, most cases were mild. The FDA has placed its highest safety warning on the prescribing label of donanemab, highlighting the risks of potentially dangerous brain swelling and bleeding.

One notable difference between donanemab and Leqembi is the concept of "finite dosing" associated with Kisunla. This means that patients can discontinue the treatment once brain scans no longer show amyloid plaques, the protein clusters responsible for Alzheimer’s symptoms. These plaques disrupt the brain's communication network and eventually lead to brain inflammation and the death of nearby healthy brain cells.

The cost of Eli Lilly’s donanemab is set at $695.65 per vial, making it slightly more expensive than Eisai’s Leqembi, which has an annual cost of $26,500. Donanemab is expected to be primarily used by patients enrolled in Medicare, the U.S. government’s health plan for individuals aged 65 and older. Medicare began covering Alzheimer’s drugs that receive standard FDA approval last year.

Besides these two treatments for early-stage Alzheimer’s, the FDA has also approved several drugs aimed at temporarily alleviating some symptoms of Alzheimer’s dementia. These include Donepezil (marketed as Aricept by Eisai), which improves attention and memory, Rivastigmine (sold as Exelon by Novartis) for mild-to-moderate Alzheimer’s and Parkinson’s disease, and Galantamine (known as Razadyne and produced by Janssen Pharmaceuticals) for treating mild to moderate Alzheimer’s disease.

The approval of donanemab marks a significant milestone in the battle against Alzheimer’s, giving patients and healthcare providers another tool to manage this challenging condition. The growing number of treatment options holds promise for better disease management and improved quality of life for those affected by early-stage Alzheimer’s.