The FDA has approved Eli Lilly’s Kisunla, an Alzheimer’s drug for early-stage dementia, marking it as the second drug proven to slow cognitive decline, following Eisai’s Leqembi. Kisunla offers a modest delay of about seven months in cognitive deterioration. However, it requires regular IV infusions and can cause side effects like brain swelling.
Neurologists, such as Dr. Suzanne Schindler, view this approval as a significant development after many failed treatments. Both Kisunla and Leqembi target amyloid plaque buildup in the brain. Kisunla’s approval came after an FDA panel endorsed its benefits despite some study concerns.
The cost for a year’s therapy with Kisunla is $32,000, compared to $26,500 for Leqembi. The FDA suggests doctors might stop the treatment once brain plaque is minimal, based on brain scans. Only patients with early or mild Alzheimer’s are eligible for Kisunla, and even fewer will navigate the complex process to get it.
Kisunla showed a 22% slower decline in cognitive abilities in an 18-month study compared to a placebo. Safety concerns include brain swelling and bleeding, with a slightly higher incidence than Leqembi. Kisunla is administered once a month, which is more convenient than Leqembi’s bi-monthly regimen.
Patients can stop Kisunla if they respond well, potentially lowering costs and risks. Logistical issues, insurance coverage, and financial challenges have hindered Leqembi’s rollout. Setting up treatment involves confirming brain plaque, finding infusion centers, and training staff to monitor side effects. Dr. Mark Mintun of Lilly’s neuroscience division notes that until these systems are established, the therapy won’t be widely offered.
