Donanemab for Alzheimer's receives approval from FDA panel

Donanemab for Alzheimer's receives approval from FDA panel

An 11-member advisory panel from the US Food and Drug Administration (FDA) unanimously concluded that the investigational anti-amyloid drug donatemab It is effective for the treatment of patients with early symptoms. Alzheimer disease (AD) and that the potential benefits outweigh the risks in this patient population.

The June 10 meeting of the Central and Peripheral Nervous System Drugs Advisory Committee was convened specifically to advise the FDA on the safety and effectiveness of the drug based on the results of the TRAILBLAZER-ALZ 2 trial.

As previously reported by Medscape Medical Newsdonanemab significantly reduced brain amyloid plaque burden and significantly slowed cognitive and functional decline compared to placebo.

After a thorough review of the data, the advisory committee voted 11-0 in favor of Eli Lily’s donanemab for the treatment of early symptomatic AD (mild cognitive defect or mild dementia).

Compelling effectiveness, manageable risks

The panel’s overall consensus was that donanemab showed “compelling” efficacy with “acceptable and manageable” risks, including the risk of amyloid-related imaging abnormalities (ARIAs), said committee chair Thomas Montine, MD, PhD. , from Stanford University in California. .

If donanemab is approved, it will be “important to minimize the risk of ARIA with careful MRI monitoring and to have detailed conversations with patients and their caregivers about the individual risk-benefit and allow patients and their caregivers to make informed decisions for themselves and your loved ones”. “Reisa Sperling, MD, of the Center for Alzheimer’s Research and Treatment, Brigham and Women’s Hospital, Massachusetts General Hospital, and Harvard Medical School, Boston, told the panel.

The TRAILBLAZER-ALZ 2 trial used amyloid and tau imaging to identify patients who were in the early stages of AD and were most likely to benefit from treatment.

However, there was general committee consensus that, if approved, tau PET imaging should not be a requirement for donanemab prescribing because it would create a barrier and “raise serious concerns about access,” Montine said.

During the public comment period preceding the committee’s vote, 20 speakers shared strong opinions both for and against the approval of donanemab, including comments from patients and caregivers who reported a dramatic slowing of cognitive decline while taking donanemab.

“Historically, patients and doctors have believed that there is nothing to slow the progression of Alzheimer’s. After a quarter of a century, we finally have evidence that we can bend the curve of cognitive decline with substantial reduction in amyloid,” Sperling said. .

In a statement sent to Medscape Medical News,Howard Fillit, MD, co-founder and chief scientific officer of the Alzheimer’s Drug Discovery Foundation, said, “It is encouraging to see some patients essentially go into remission, where they achieve complete clearance of amyloid with donanemab, without resurgence of substantial plaque buildup for almost 4 years.”

“These findings are a direct result of biomarker testing that can detect, quantify, and monitor plaque buildup in the brain. Biomarkers will continue to revolutionize clinical trial design as we move toward developing drugs that target new pathways.” guided by the biology of aging. Fillit said.

Sperling noted that with current monoclonal antibodies, “we are not yet fully successful, but right now it is critical to do everything we can to make an impact in slowing this terrible, inexorably progressive neurodegenerative disease so that older people can enjoy this time”. with their families for whom they have worked all their lives.

Fillit said the committee’s endorsement “offers hope that donanemab will be approved in the coming months, but it is important to look at this milestone in the broader treatment landscape for Alzheimer’s, which will involve a combination therapy and precision medicine approach.” .

“If approved, donanemab will expand the first class of disease-modifying drugs, serving as a foundation for future generations of drugs. Anti-amyloids are not a silver bullet, but they offer opportunities for patients to modify the course of the disease while “This field is working to develop more novel therapies that target the underlying biology,” Fillit said.

The members of the advisory panel have no relevant disclosures. Sperling has been a consultant to several companies developing treatments for Alzheimer’s disease for the past 3 years. Fillit has no disclosures.

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