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It's on Monday, A panel of independent advisers to the US Food and Drug Administration has voted to support Eli Lilly's drug donanemab, a monoclonal antibody designed to slow the progression of early signs of Alzheimer's disease, agreeing that the drug is safe and effective.
One in three elderly Americans will die of Alzheimer's disease or another form of dementia. According to the Alzheimer's AssociationKilling more people than prostate and breast cancer combined.
Donamab works by helping the body get rid of the amyloid plaque deposits in the brain that are the hallmark of Alzheimer's disease. These plaques are harmful deposits that can build up in the brain as people age. Removing the plaque appears to slow the brain changes that appear to occur with Alzheimer's.
When the drug enters the brain, it binds to amyloid plaques and its presence attracts the attention of the immune system, which facilitates the removal of the plaque.
There is still no cure for Alzheimer's disease: Donanumab and another drug called Lekumbi are being marketed by Isa and Biogen. .
Lilly told the FDA's Peripheral and Central Nervous System Drug Advisory Committee. His data from Late-stage clinical research It showed a “highly significant effect” for patients who received donamab, with a 37% lower risk of developing the disease compared to patients who received a placebo.
Serious adverse events were “generally comparable” among all groups in the trials, and rare, Lilly told the committee, occurring in only 2% of patients. Patients on donanemab had a slightly higher death rate – 2%, compared to 1.7% in the placebo arm of the trial.
Three people died while taking the drug after developing microarrays known as ARIA, or amyloid-related imaging abnormalities.
With lekambi, a drug already on the market, some patients experienced ARIA, but it was less than seen in the donanemab trial. He also has a taster. He is arrested For patient death.
Lilly told the committee that since most of the donumab patients who developed ARIA did so in the first six weeks of the trial, he added another MRI to the trial to look for the problem before giving the patient a second infusion. The aim is to find patients with asymptomatic ARIA. If found, providers will pause treatment to allow it to resolve and not become more serious or symptomatic.
Looking at these results from late-stage clinical trials, the FDA committee voted Two special questions And we discussed three other main topics.
The committee voted unanimously “yes” to the questions that the data showed that the drug was effective in treating Alzheimer's disease and that the drug's benefits outweighed the risks of Alzheimer's treatment in people enrolled in clinical trials. .
The FDA takes the committee's advice into account when it decides to green light the drug.
Committee member Dr. Dean Folman, assistant director of biostatistics at the National Institute of Allergy and Infectious Diseases, voted yes because the evidence was “strong and consistent across subgroups.”
Voting yes, Sarah Dolan, acting consumer representative on the committee and a consultant with the Critical Path Institute in Tucson, Arizona;, She said she was pleased with the results of the study.
“There's a huge unmet medical need here that can hopefully be addressed,” Dolan said.
Committee member Dr. Kathleen Poston, director of Stanford's Center for Movement Disorders, voted yes, believing the drug has benefits “as long as the risks are controlled.”
The trials included only patients with low-to-moderate levels of tau, a protein that is abnormal and contributes to the disease. Lilly excluded patients with no or very low tau because the study did not follow patients long enough to see if the drug made a difference. They also excluded people with high levels of tau. The committee had some concerns about extrapolating the results to other patients with tau levels. Wanted to see more data.
Most of the committee was not comfortable with the fact that the FDA requires a tau PET test to determine if a patient is eligible to receive the drug. Because the test is not widely available and it makes it difficult for some people to take the medicine.
FDA also asked the committee to consider additional factors related to ongoing research and drug administration.
Lilly suggests that patients can stop the medication if they show sufficient improvement. The committee recommended studies on what criteria would be used to stop or restart the drug if symptoms return. The committee also noted that there was little diversity in the trial, as most of the participants were white, and that future research needs to include more people of color to understand how the drug works in different populations. The committee also suggested that if the drug is approved, doctors will have to educate their patients about the benefits and risks of taking this drug.
Initially, when the FDA said it would hold this meeting, it came as a Amazing announcement Many experts think that the drug will be approved by the FDA last year.
Before the vote, Dr. Raysa Sperling, a professor of neurology at Harvard Medical School, told the committee that if left untreated, the rising number of people with Alzheimer's disease could pose a serious threat to the nation.
“We're doing a good job of keeping people alive. If we don't find a way to prevent this disease, we're creating a public health emergency,” Sperling said.
Meanwhile, Lilly said he is working on more Alzheimer's treatments.
Eli Lilly and the company's chief medical officer, Dr. David Hyman, told the committee that “recognizing the enormous burden this disease carries, we are committed to bringing a well-known disease-modifying treatment to patients.”
Lilly sees Donumab as a “helpful but ultimately incremental” step in the treatment of Alzheimer's disease. Ultimately, Hyman Lilly wants to develop a drug that treats the disease before a person shows symptoms and works on such a drug.
“Patients deserve more, and we're going to do more to fight this disease,” Hyman said.
After the meeting, Lilly said she was pleased with the committee's positive vote.
“We are pleased that the committee unanimously found a positive benefit-risk profile for donamab,” Mark Mintun, Eli Lilly's vice president of neuroscience research, said in a news release. “We look forward to bringing this treatment option to patients.”
The Alzheimer's Association urged the committee to approve donamab, and the committee unanimously approved the drug.
“The future of more widely accepted Alzheimer's treatments for people who qualify for these drugs is a big step forward,” said Dr. Joanne Pike, president and CEO of the Alzheimer's Association. “Progress is being seen in the treatment process.”
USA Against Alzheimer's, which testified in favor of the drug during public comment at the meeting, said there is an urgent and “huge unmet need” for Alzheimer's treatments.
“If approved by the FDA, donamab will be the second drug on the market to help people with early-stage Alzheimer's live longer and better quality of life, and will provide patients and their physicians with another treatment option. Plans,” said Chairman and Co-Founder George Vradenberg. “The Advisory Committee's support for this promising treatment Thank you for giving us.”