FDA Approves Kisunla, Second Alzheimer’s Disease Drug Slowing Cognitive Decline

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In a landmark decision, U.S. officials have sanctioned another pharmaceutical armament in the ongoing battle against Alzheimer’s disease. This newly approved drug represents a small, yet significant stride in slowing the unforgiving progression of the cognitive ailment, furnishing therapeutic options for patients in the early onset of this indomitable, memory-eroding disease.

The green light was given to Eli Lilly’s drug Kisunla by the Food and Drug Administration. This authorization specifically covers mild or early manifestations of dementia incited by Alzheimer’s disease. It proudly stands as the second drug substantiated by compelling clinical evidence to hinder cognitive decline in patients, close behind last year’s endorsement of a similar medication by Japanese pharmaceutical company Eisai.

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For the patients receiving either of these drugs, the delay in cognitive decline equates to a precious few months—roughly seven, in the case of Lilly’s product. Patients, along with their families, now face the challenging task of balancing this tangible benefit against potential discomforts. The frequent necessities of intravenous infusions, along with a risk of severe side effects like brain swelling, pose significant considerations for patients and caregivers.

Alzheimer’s specialists, however, view this approval as an individual triumph in a series of setbacks spanning decades of failed experimental treatments. Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis, expressed her excitement with the unfolding pharmaceutical landscape. As a veteran in the battle against dementia, Schindler has witnessed far too many of her patients’ relentless battles with the disease, inevitably progressing until their demise.

Similarities between Kisunla and the Japanese drug Leqembi are striking, as both are synthetic antibodies administered via IV, aimed at a single adverse factor associated with Alzheimer’s—the infamous amyloid plaque accruing within the brain. Unanswered questions linger as to which group of patients will be most suitable for such treatments and for what duration they might see benefits.

Eli Lilly’s breakthrough faced concerns during the approval process, including the company’s methodology of allowing patients to discontinue the drug once their plaque accumulation sunk to near indiscernible levels. In terms of cost, the patients’ expense will fluctuate based on the duration of the treatment however Lilly revealed that an annual treatment duration would be priced at $32,000—somewhat more than the $26,500 cost for Leqembi.

Over 6 million Americans are grappling with Alzheimer’s, but only those with early or mild forms of the disease will qualify for this new treatment. A much smaller demographic will be able to navigate the multi-step procedure necessary to acquire a prescription.

The FDA authorized Kisunla, known chemically as donanemab, based on data from an 18-month study. During the study, patients receiving the treatment experienced a delay in cognitive and memory decline roughly 22% more than subjects receiving a dummy infusion.

Paramount safety concerns revolved around brain swelling and hemorrhage, issues that are common to all plaque-targeting drugs. Figures reported by Lilly, including 20% of patients who experienced microbleeds, were marginally higher than its competitor Leqembi. Such drugs, however, were tested on slightly variant patient groups, rendering comparisons of safety challenging.

One edge Kisunla offers is convenience: it is administered once a month as opposed to Leqembi’s bi-monthly regimen, a silver lining for caregivers who transport their loved ones to hospitals or clinics for treatment.

Additionally, the company’s trial revealed a potential advantage unique to Kisunla: almost half its patient participants were able to discontinue their course after their brain plaque dropped to nearly undetectable levels. Cutting short the course of medication could potentially reduce both cost and risks attached to long-term use. However, the question of when patients should resume treatment remains unanswered.

Certain logistical challenges, coupled with inconsistent insurance coverage and financial barriers, have tempered the introduction of competitor Leqembi, which Eisai co-sells with U.S. partner Biogen. Multiple smaller hospitals and healthcare providers have yet to establish protocols needed to administer these advanced Alzheimer’s treatments.

To commence treatment, physicians not only have to detect the existence of brain plaque in dementia patients but also locate a suitable infusion center offering therapeutic services. Simultaneously, healthcare staff must be trained to conduct repeated scans to monitor any signs of brain swelling or hemorrhage.

Dr. Mark Mintun, who leads Lilly’s neuroscience division, acknowledged the demanding processes physicians must overcome before they can offer the therapy. The way ahead is challenging yet undeniably hopeful, he suggested, as the medical community learns to adapt to the new treatments.