Health
FDA advisers unanimously approve Alzheimer's drug
An FDA advisory committee on Monday unanimously endorsed the investigational drug donanemab as a treatment for early-stage Alzheimer's disease.
In an 11-0 vote, the Peripheral and Central Nervous System Drugs Advisory Committee stated that the benefits of donanemab outweigh the risks for the population of Alzheimer's patients with mild cognitive impairment and mild dementia who participated in donanemab's clinical trials.
The committee also voted 11-0 that available data show that donanemab is effective in treating this group of patients with Alzheimer's disease. I expressed my concerns last week. Although Alzheimer's patients with no or very low tau were excluded from the pivotal trials of donanemab, the committee overall agreed that the drug should not be restricted to Alzheimer's patients with a particular tau burden.
“The population-based evidence in this trial is very strong and consistent across subgroups,” said committee member Dean Folman, PhD, a biostatistician at NIH.
“The biomarker data also supported efficacy,” added committee member Kathleen Poston, M.D., of Stanford University in California. “The benefits outweigh the risks, as long as the risks are monitored.”
But during the meeting, Poston and his colleagues expressed concern about the lack of data on donanemab and other anti-amyloid drugs in African-American and Hispanic people. “Going forward, it's going to be important to have that data to make sure that these promising findings apply to the entire population of people with Alzheimer's,” Poston said.
FDA advisers suggested that while the risks of amyloid-related imaging abnormalities (ARIA) were evident in the trial data, many of them could be mitigated. Safeguards could be put in place to manage ARIA, and the risks “could be safely uncovered through the proposed MRI program and training,” noted Cynthia Carlson, MD, PhD, a member of the committee on medicine and public health at the University of Wisconsin-Madison.
Marwan Sabbagh, MD, a neurologist at Barrow Neurological Institute in Phoenix, who was not involved in the donanemab trial, summarized the views of most Alzheimer's patients who spoke at the conference hearing: “Patients with Alzheimer's have a 100% chance of worsening and losing their independence, compared to a 6% chance of having symptomatic ARIA,” Sabbagh said.
Donanemab was tested in a phase 3 clinical trial. Trailblazer ALZ2 The study included 1,736 patients with early-stage Alzheimer's disease. The drug met the study's primary endpoint of change from baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS), slowing the decline compared to placebo (PThe drug also met its ranked secondary endpoint of less decline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 76 weeks (P<0.001).
As with other anti-amyloid drugs, safety issues with donanemab have focused on ARIA with edema or exudate (ARIA-E) and ARIA with microhemorrhages and hemosiderin deposits (ARIA-H). Apoe 4 Homozygotes are at higher risk of infection than heterozygotes and non-carriers.
In TRAILBLAZER-ALZ 2, ARIA-E occurred in 24% of donanemab-treated participants and ARIA-H occurred in 31.4%. Two ARIA-related deaths were due to donanemab.
If approved, donanemab would be the third amyloid-targeting drug to reach the market. The first was the controversial aducanumab (Aduherm), which received accelerated approval. It was then abandoned, The second is Lecanemab (Leqembi); Fully FDA approved last year.
The FDA has not released a date for a final decision on donanemab. The FDA is not required to follow the advisory committee's recommendations but typically does.
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Sources 2/ https://www.medpagetoday.com/neurology/alzheimersdisease/110575 The mention sources can contact us to remove/changing this article |
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