An experimental Eli Lilly drug for Alzheimer’s treatment was approved last week for use in Japan, which has one of the world’s largest aging populations. The U.S. Food and Drug Administration approved Kisunla to slow cognitive functional decline three months ago. Japan is the first country to follow suit.
The once-monthly injection for IV infusion, targets and removes Amyloid, a naturally occurring protein in the brain that can clump together and lead to cognitive decline and memory loss. This is the first amyloid-plaque therapy approved in treating adults with early symptoms of Alzheimer’s disease or mild cognitive impairment, as well as mild dementia.
“Alzheimer’s disease is a significant healthcare burden in Japan due to the rapidly aging population,” said Yanping Wang, senior vice president of Drug Development and Medical Affairs at Eli Lilly Japan in a press statement.
In Japan, 4.6 million people suffer from dementia, a condition which impairs memory and cognitive function, and Alzheimer’s disease is the most common form of dementia. In the US that number is 6.7 million, considering the US population is almost three times larger than Japan’s.
“Aging is a big factor there, and it’s a big factor here in America,” said Jasper Hellweg, associate analyst at Argus Research, an investment research firm.
Hellweg believes Kisunla’s FDA approval is a “massive” opportunity for Eli Lilly’s market growth, although perhaps not as rocketsized as Zepbound’s. Last year Lilly released its first anti obesity drug Zepbound that uniquely targeted GLP-1 hormones, which skyrocketed sales and led to a nationwide shortage. Lilly’s diabetes and weight-loss drugs Zepbound and Mounjaro, together with breast cancer drug Verzenio, accounted for 36% of Lilly’s revenue this second quarter.
Those drugs “led our strong financial performance in the second quarter,” said David A. Ricks, Lilly’s chair and CEO in an August press release.
Kisunla was successful in “significantly” slowing cognitive and functional decline in a clinical study which included Japanese participants, the company said. The results of the clinical trial held promise, with 61% of patients showing a reduction in plaques after only six months and 80% after a year.
It took “decades in the making,” said Ricks. Pharmaceutical drugs typically take 10 years to develop and ultimately sell, that is, if they make it past the FDA’s regulatory stamp of approval. Scientific investments such as technology and research are necessary for drug development, but are also time intensive and expensive, which makes for the company’s high R&D costs. Eli Lilly invested 25% of its R&D costs in 2022. This was higher than its industry peers, according to a note by investment firm MorningStar.
Lilly reports its third-quarter results Oct. 30.