United States: On Monday, an advisory group of the U.S. Food and Drug Administration unanimously recommended that the advantages of a novel Alzheimer’s medication surpass its drawbacks, which may include bleeding and swelling of the brain which can cause to several health related issues though this is could be very dangerous as well.
Company Data Supports Efficacy
Eli Lilly’s donanemab helped people with early-stage Alzheimer’s disease slow down the loss of their cognitive abilities: According to company data, patients who received donanemab during an 18-month period had a 37% lower probability of the disease progressing than those who received a placebo.
FDA Scrutiny and Advisory Group Evaluation
Originally, the FDA had planned to approve the drug earlier this year, but in March, it decided to have an independent advisory group examine donanemab instead.
The group on Monday came to the conclusion that the effects of Alzheimer’s are so severe that even a small benefit can be valuable, considering that over 6 million Americans suffer from the disease and that neither a cure nor a change in lifestyle can restore memory loss.
The consumer representative on the panel, Sarah Dolan, told the New York Times that “there is a huge unmet need here.”
Donanemab acts by going after amyloid, a protein that builds up in the brains of sufferers.
Recently, two comparable amyloid-fighting medications were approved. Similar to donanemab in terms of dangers and moderate benefits, Eisai and Biogen’s Leqembi was approved last year. Aduhelm, another Biogen product, was authorised in 2021 but was then withdrawn due to insufficient patient benefit data.
Consideration of Disease Severity
The panel vote on Monday elicited a mixed response.
For those who qualify, a future with more authorised Alzheimer’s medicines is a huge advancement. Joanne Pike, the president and CEO of the Alzheimer’s Association, stated in a statement that “treatment progress is happening.”
We now require a wider range of safer and more effective therapy options that address different facets of the illness. This will open up opportunities for combination treatments that take into account the disease’s complexity, Pike continued.
Public Health Concerns and Advocacy
“I was really disappointed with the advisory committee meeting. Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group, stated in a statement that the fundamental question was not whether donanemab should be allowed initially, but rather whether the drug’s possible prescription advice should be specified. “Aduhelm and Leqembi, two medications for Alzheimer’s disease, should never have been approved by the FDA. It shouldn’t approve Donanemab and commit the same error a third time.”
“More therapy options that are safer and more effective are now required, addressing different facets of the illness. This will open up the possibility of combination therapy to deal with the disease’s complexity, Pike continued.
The nonprofit consumer advocacy group concluded in a statement that “all three drugs have the same problem: their purported benefits in slowing the progression of Alzheimer’s disease do not outweigh their substantial health risks, including brain swelling and bleeding.” “Donanemab is not the solution and should not be approved, despite the fact that patients with Alzheimer’s disease and their families are in dire need of effective treatments.”
According to trial data that Lilly provided to the FDA, patients on donanemab experienced slower cognitive declines than those who received a placebo by roughly 4½ to 7½ months.
Continued Debate and Uncertainties
Conversely, donanemab-related brain haemorrhage or edoema claimed the lives of three people.
Some panel members found Lilly’s choice to cease treating patients as soon as a brain scan showed their amyloid had cleared appealing because it allowed patients to avoid ongoing monthly injections, treatment risks, and increased medical expenses, according to the Times.
The committee was still unsure about stopping the therapies.
Weill Cornell Medicine’s Dr. Constantino Iadecola in New York City pointed out that it was unclear how patients would be followed up with once they stopped taking the medication.
He informed the Times that “monitoring is going to be necessary.” Furthermore, he said, “How soon will you have to intervene if you have an amyloid signal going up?”
Lilly scientists have estimated it would take nearly four years for amyloid levels to bump up over the threshold again.