US health officials have given the green light to a second Alzheimer’s drug that could slightly impede the progression of the disease, providing fresh hope for those suffering from early stages. The Food and Drug Administration has endorsed Eli Lilly’s Kisunla, specially formulated for mild or preliminary cases of dementia caused by Alzheimer’s.
Remarkably, it is only the second drug with compelling evidence to stave off cognitive deterioration in patients, following last year’s approval of a similar medication created by Japanese pharmaceutical company Eisai. However, the slowdown experienced with both remedies equates to merely months.
In the case of Lilly’s Kisunla, around seven months. This offers patients and their caregivers food for thought when considering the modest benefits against drawbacks such as routine IV drips and severe potential side effects like brain swelling.
Medical professionals dealing with Alzheimer’s deem this approval as a significant leap forward, especially after countless failed clinical trials spanning decades. Neurologist Dr Suzanne Schindler of Washington University in St Louis expresses her excitement: “I’m thrilled to have different options to help my patients,” she states.
However, there were still challenges: “It’s been difficult as a dementia specialist – I diagnose my patients with Alzheimer’s and then every year I see them get worse and they progress until they die.”, reports the Liverpool Echo.
Both, Leqembi the medicine developed by the Japanese firm and Kisunla are lab-produced antibodies that target one factor leading to Alzheimer’s: the notorious amyloid plaque buildup in the brain. Nonetheless, doubts linger about who should receive these treatments and for how long they might relay benefits.
The approval of the new drug was anticipated after an external panel of FDA advisers unanimously voted in favour of its benefits at a public meeting last month. This endorsement came despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to discontinue treatment after their plaque reached very low levels.
Lilly stated that costs would vary by patient, based on how long they take the drug. The company also revealed that a year’s worth of therapy would cost £25,256 – higher than the annual price of Leqembi, which is £20,920.
The FDA’s prescribing information advises doctors to consider stopping the drug after confirming via brain scans that patients have minimal plaque. The FDA approved Kisunla, known chemically as donanemab, based on results from an 18-month study in which patients given the treatment declined about 22% more slowly in terms of memory and cognitive ability than those who received a placebo infusion.
The main safety issue was brain swelling and bleeding, a problem common to all plaque-targeting drugs. The rates reported in Lilly’s study – including 20% of patients with microbleeds – were slightly higher than those reported with competitor Leqembi.
However, the two drugs were tested in slightly different types of patients, which experts say makes it difficult to compare the drugs’ safety.
Kisunla requires a monthly infusion compared to Leqembi’s bi-weekly regimen, making it more convenient for caregivers assisting their loved ones in hospitals or clinics. “Certainly getting an infusion once a month is more appealing than getting it every two weeks,” stated Dr Schindler.
An additional potential advantage of Lilly’s drug lies in its usage flexibility: if patients demonstrate positive response, they may cease taking Kisunla.
In the company’s assessment, patients were taken off Kisunla after their brain plaque levels had sufficiently reduced. This stoppage could decrease associated costs and safety risks connected to long-term use.
The timeline indicating when patients might need resuming infusions is yet to be defined.
