FDA Approves Kisunla (Donanemab) to Treat Alzheimer's

In early July, the U.S. Food and Drug Administration (FDA) approved Kisunla (donanemab) for the treatment of people living with early symptomatic Alzheimer's disease, which includes mild cognitive impairment and the mild dementia stage of the disease, with confirmed amyloid plaques.

Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study, and reduced participants' risk of progressing to the next clinical stage of disease by up to 39%.

Kisunla is the first and only amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal. Nearly half of study participants completed their course of treatment with Kisunla in 12 months.

"Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer's disease, who urgently need effective treatment options," said Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly and Company.

"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," said White. "Each year, more and more people are at risk for this disease, and we are determined to make life better for them."

"This is real progress," said Joanne Pike, DrPH, Alzheimer's Association president and CEO. "Today's approval allows people more options and greater opportunity to have more time.

"Having multiple treatment options is the kind of advancement we've all been waiting for - all of us who have been touched, even blindsided, by this difficult and devastating disease."

Because multiple FDA-approved Alzheimer's treatments are now available, early detection and diagnosis are even more critical to ensure individuals receive the most benefit.

"Too many roadblocks have prevented individuals from getting equitable access to these beneficial treatments for far too long," said Pike.

"It is equally important that clinicians and health care systems are informed and prepared to help the individuals who could benefit. The Alzheimer's Association is working with health systems and providers to ensure they have the tools and resources to meet the needs of their patients."

The association strongly encourages prescribers to participate in the Alzheimer's Network for Treatment and Diagnostics (ALZ-NET), which is gathering real world data on how people from all backgrounds and communities respond to novel FDA-approved Alzheimer's therapies.

ALZ-NET provides ongoing education and resources for clinicians, patients and families, helping them stay informed about the latest developments in Alzheimer's research and care.

"These recent approvals generate hope for continued advances. For researchers, our next horizon is to develop new treatments that address different components of the disease, and that work together to have an even bigger effect on slowing or stopping disease progression for all communities," said Maria C. Carrillo, Ph.D., chief science officer and medical affairs lead, Alzheimer's Association.

This is the third approval of an Alzheimer's treatment that changes the underlying course of the disease.

"Today's decision by the FDA is good news for those of us living with early Alzheimer's," said Barbara Eades of Chattanooga, Tennessee, who was diagnosed with mild cognitive impairment in 2018.

"I was fortunate to participate in the clinical trial and receive this treatment. It has provided me an opportunity to live my life fully, for more time."