FDA approves a second Alzheimer's drug that can modestly slow disease

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s new drug, Kisunla, for mild or early cases of Alzheimer’s dementia. Kisunla is the second drug to be convincingly proven to delay cognitive decline in Alzheimer’s patients, following last year’s approval of a similar drug from Eisai.

The benefits of Kisunla consist of a modest slowing down of the disease progression, with about a seven-month delay observed. However, patients and their families should weigh this advantage against the challenges, such as regular intravenous infusions and potential dangerous side effects, like brain swelling.

While many physicians view this approval as a critical step after years of failed Alzheimer’s treatments, it is important to remember that both Kisunla and Leqembi work by targeting a specific contributor to Alzheimer’s – sticky amyloid plaque buildup in the brain. Some questions remain concerning which patients should receive these drugs and their potential long-term benefits.

The FDA approved Kisunla, also known as donanemab, based on 18-month trial results, revealing that patients given the treatment declined around 22% slower in memory and cognitive ability compared to those receiving a placebo. The main safety issue with both drugs is brain swelling and bleeding, a risk common in plaque-targeting drugs, albeit with slightly higher rates reported for Lilly’s drug than Leqembi, based on the studies performed.

Importantly, Kisunla is infused monthly, instead of twice a month like Leqembi, potentially providing an advantage to patients and caregivers. Additionally, the drug is designed to allow patients to stop taking it when they respond well to the treatment. Moreover, discontinuing the drug could help mitigate long-term costs and safety risks. The optimal time to resume treatments is yet unknown.

Finally, logistical hurdles, insurance coverage, and financial issues have slowed down the availability of Leqembi to many hospitals and healthcare systems. Initially, doctors will need to diagnose patients and locate treatment centers offering drug infusion services before patients can receive treatment. Nurses and other staff may also need specialized training to perform regular brain scans monitoring for swelling or bleeding associated with these drugs. This infrastructure can take time to build up, causing a delay in access to new treatments for some Alzheimer’s patients.

.st1{display:none}See more