Approvals

Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved Kisunla (donanemab-azbt, 350mg/20ml once-monthly injection for IV infusion) for the treatment of adult patients with early symptomatic Alzheimer’s disease (AD).

The drug is now approved for this indication, including people with mild cognitive impairment (MCI) and those with mild stage dementia AD with confirmed amyloid pathology.

Once monthly treatment with the drug is the ‘first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions’, according to the press release.

Anne White, executive vice president and president of Lilly Neuroscience at Eli Lilly and Company, commented: “Kisunla demonstrated very meaningful results for people with early symptomatic AD, who urgently need effective treatment options. We know these medicines have the greatest potential benef it when people are treated earlier in their disease, and we are work ing 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 programmes, 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.”

“This approva l 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,” said Howard Fillit MD, co-founder and chief science officer at the Alzheimer's Drug Discover y Foundation (A DDF). “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.”