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Alzheimer’s doctor says Lilly drug’s FDA approval is ‘big breakthrough’

Last Updated 3 weeks by Amnon J. Jobi | Amnon Front Page

FDA approves Lilly drug for Alzheimer’s disease

INDIANAPOLIS (WISH) — A new Lilly drug is giving hope to the Alzheimer’s disease community.

The drug, Kisunla — also known by the generic name donanemab — can reduce cognitive decline in Alzheimer’s patients by 35%.

The drug received FDA approval on Tuesday. The FDA approved a similar infused drug, Leqembi, from Japanese drugmaker Eisai last year.

Dr. Howard Fillit is the co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation. He has been at the helm of Alzheimer’s treatment advancements for much of his career.

“It really is a big breakthrough. It’s very, very exciting, and it proves a theory that’s been around for 40 years, which is that this beta-amyloid protein plays a role in the disease process, and the beta-amyloid plaques that occur in the brain, which are removed by drugs like donanemab or Kisunla.”

The drug will be administered by infusion once a month. The trial was administered over 18 months but stopped when a patient’s brain was clear of beta-amyloid plaques. This could be in the six-month range, but around half of the patients were on the drug up to 12 months. Some patients were on the drug for the full 18 months.

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Fillit said patients will often go into a type of remission after their treatment is over. They will be monitored with PET scans (positron emission tomograph), and a new course will start if the Alzheimer’s causing plaque comes back to the brain.

“If the plaques are gone on the PET scan, we can stop the drug, and that’s a real innovation in our field. And it’s been shown that, in some of the data, in the long-term follow-ups, it takes about 3-4 years for the plaque to reaccumulate.”

Fillit said the Lilly drug is not the end. Researchers will start on other treatments for Alzheimer’s to bring cases down.

“It’s very rewarding that we have treatments on the market but, as we said earlier, these treatments only slow it down by 35%, so what we want to do is slow it down by 100% or even prevent it.”

The exact cost of Kisunla remains to be determined, but the drug will be more accessible because it is not a drug patients need to take indefinitely.

Fillit also said the drug could be available as early as the end of the summer, but that is dependent on manufacturing and rollout.

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Images of Kisunla. (Provided Images/Eli Lilly & Co.)

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