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

The U.S. Food and Drug Administration (FDA) has approved another drug, Kisunla, for treating Alzheimer’s disease. This approval marks the second drug that has been shown to delay cognitive decline in patients, following last year’s approval of a similar drug from Japanese drugmaker Eisai. Kisunla is for mild or early cases of dementia caused by Alzheimer’s, and the delay in disease progression seen with both drugs is around seven months for Kisunla. However, the treatment involves regular IV infusions and may cause side effects like brain swelling.

Physicians find this approval significant after decades of unsuccessful Alzheimer’s treatments. A neurologist, Dr. Suzanne Schindler, stated that she is thrilled to have additional options to help her patients, as the current progression of the disease can be difficult to manage.

Kisunla, also known as donanemab, is a laboratory-made antibody that targets amyloid plaque buildup in the brain, which is a contributor to Alzheimer’s. Questions remain about the suitable patients for these drugs and the duration of their effectiveness.

The FDA based its approval on results from an 18-month study, where patients given Kisunla declined about 22% more slowly in terms of memory and cognitive ability compared to those who received a dummy infusion. The main safety concern was brain swelling and bleeding, common issues with all plaque-targeting drugs. The reported rates in Lilly’s study were slightly higher than those of competitor Leqembi, but experts note that the two drugs were tested on slightly different patient types, making direct comparisons challenging.

Kisunla is infused once a month compared to Leqembi’s twice-a-month regimen, which could be more convenient for caregivers. Moreover, patients can discontinue Kisunla if they respond well, potentially reducing costs and safety risks of long-term use. However, it is yet unclear when patients might need to resume infusions.

Logistical hurdles, insurance coverage issues, and financial concerns have slowed the rollout of Leqembi, the competitor co-marketed by Eisai and Biogen in the U.S. Many smaller hospitals and health systems may not be equipped to prescribe the new Alzheimer’s drugs. Doctors first need to confirm that patients have the brain plaque targeted by the new drugs, find an infusion center where patients can receive therapy, and ensure their staff is trained to perform repeated scans to check for side effects. Until these processes are streamlined, patients may not have access to these therapies.

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