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The US Food and Drug Administration (FDA) has approved Eli Lilly’s anti-amyloid donanemab (Kisunla) 350 mg/20 mL once-monthly injection for intravenous infusion for adults with early symptomatic Alzheimer’s disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease with confirmed amyloid pathology.
Once-monthly donanemab 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,” Eli Lilly said in a statement announcing approval.
“This is real progress. Today’s approval allows people more options and greater opportunity to have more time,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO.
“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,” Pike said.
As previously reported by Medscape Medical News, the FDA approval follows last month’s unanimous thumbs up by an 11-member FDA advisory panel, which concluded that the anti-amyloid agent is effective for the treatment of patients with MCI or mild dementia and that the potential benefits outweigh the risks in this patient population.
Approval was based on positive data from the phase 3 TRAILBLAZER-ALZ 2 trial, which showed that donanemab significantly reduced brain amyloid plaque burden and significantly slowed cognitive and functional decline compared with placebo in early symptomatic AD.
“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,” Howard Fillit, MD, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation (ADDF), said in the Eli Lilly statement.
“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,” Fillit commented.
Participants in the TRAILBLAZER-ALZ 2 study were able to complete treatment and switch to placebo at 6, 12, or 18 months after they achieved minimal levels of amyloid plaque consistent with a visually negative amyloid PET.
In the overall population of patients receiving donanemab, 17% completed treatment at 6 months, 47% at 12 months, and 69% at 18 months on the basis of an assessment of amyloid levels via an amyloid PET.
The FDA’s dosing instructions state that prescribers can consider stopping the drug based on removal of amyloid plaques to minimal levels as observed on amyloid PET imaging.
According to Eli Lilly, the price of each vial of donanemab is $695 before insurance. A 6-month course of treatment would cost $12,522; a 12-month course, $32,000; and an 18-month course, $48,696. Patients’ out-of-pocket cost for donanemab will depend on their length of treatment and their insurance.
Like other anti-amyloid agents, donanemab carries the risk for amyloid-related imaging abnormalities (ARIAs).
The general consensus from the FDA advisory panel was that donanemab showed “convincing” efficacy with “acceptable and manageable” risks, including the risk for ARIAs, said Committee Chairperson Thomas Montine, MD, PhD, with Stanford University in California.
Reisa Sperling, MD, with the Center for Alzheimer Research and Treatment, Brigham and Women’s Hospital, Massachusetts General Hospital and Harvard Medical School, Boston, told the panel, if donanemab is approved, it will be “important to minimize risk of ARIA with careful MRI monitoring and to have detailed discussions with patients and care partners regarding individual risk-benefit and allow patients and their care partners to make informed decisions for themselves and their loved ones.”
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