Lilly drug to slow Alzheimer’s disease gains FDA approval
INDIANAPOLIS (WISH) — Lilly’s drug that can slow Alzheimer’s disease has received the approval of the U.S. Food and Drug Administration, the Indianapolis-based pharmaceutical giant announced Tuesday.
FDA advisers voted unanimously in June that donanemab’s ability to slow the disease outweighs its risks, including side effects like brain swelling and bleeding that will have to be monitored.
The drug, known commercially as Kisunla, became the second Alzheimer’s drug cleared in the U.S. that’s been shown to convincingly slow cognitive decline and memory problems due to Alzheimer’s.
The FDA approved a similar infused drug, Leqembi, from Japanese drugmaker Eisai last year.
A news release from Lilly says Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in a study, and reduced participants’ risk of progressing to the next clinical stage of disease by up to 39%
Kisunla is a therapy that targets amyloid plaque found in the brain, a known feature of people with Alzheimer’s disease.
The therapy involves once-monthly infusions of 30 minutes, which were found to reduce amyloid plaques on average by 84% compared to the start of the study, Lilly says.
Despite the announcement on the Alzheimer’s drug, Lilly stock fell last than 1% Tuesday after President Joe Biden and Sen. Bernie Sanders called for Lilly and a rival to make price cuts on weight-loss and diabetes drugs.
Previous reporting from The Associated Press contributed to this report.
Statements
“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options. We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis. Our deepest thanks to the patients and their loved ones for participating in our clinical programs and to Lilly scientists and collaborators persevering over decades of research. Each year, more and more people are at risk for this disease, and we are determined to make life better for them.”
Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly & Co.
“This approval marks another step forward in evolving the standard of care for people living with Alzheimer’s disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer’s community. As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients. Diagnosing and treating Alzheimer’s sooner than we do today has the potential to meaningfully slow disease progression, giving patients invaluable time to maintain their independence for longer.”
Dr. Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation
“We are encouraged by the FDA’s approval of donanemab and are optimistic that it will make a positive difference in the lives of individuals living with Alzheimer’s disease and their family caregivers. As with any medication, patient access and affordability to all those in need is vitally important, and we hope the FDA’s actions will facilitate both.
“This is another positive sign of further progress, but we must keep moving forward until we reach the finish line — a cure for Alzheimer’s disease. Federal policymakers must continue increasing investments in Alzheimer’s disease research and support services for caregivers to provide help and hope to the millions of Americans living with Alzheimer’s.”
Alzheimer’s Foundation of America via Sandy Silverstein
“Alzheimer’s disease is a devastating disease for the person diagnosed and their loved ones. The trial data demonstrated, convincingly, that Kisunla reduces the rate of cognitive and functional decline in patients in the mild cognitive impairment and mild dementia stages of Alzheimer’s disease. Today’s approval is evidence of the FDA’s commitment to helping more safe and effective drugs to treat Alzheimer’s disease become available.”
Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research