What you should know about the newly approved Alzheimer’s drug
#newly #approved #Alzheimers #drug Welcome to Alaska Green Light Blog, here is the new story we have for you today:
Jan. 6, 2023 — The highly anticipated Alzheimer’s drug lecanemab received accelerated approval status from the FDA this afternoon, offering hope where there has been little for patients and their families affected by the devastating disease.
More than 6 million people in the US are living with Alzheimer’s.
It is not a cure, but the drug given intravenously every 2 weeks has been shown moderate positive effects in clinical Studies on slowing down early stage diseases.
But many are cautious. As explained in an editorial last month in the magazine The lancet“The Alzheimer’s community has become accustomed to false hope, disappointment and controversy.”
Some are concerned about the safety of lecanemab because some people in clinical trials experienced serious side effects, such as bleeding and swelling in the brain. scientists recently attributed a third death to lecanemab, brand name Leqembi, although the drug manufacturer controversial the drug was the cause.
So what should patients and their families do with today’s news? Here we answer some of the most important questions about the drug.
What does today’s FDA action mean?
The FDA granted Leqembi accelerated approval after it showed positive trial results in slowing the progression of the disease in early stages.
The FDA can grant accelerated approval for medicines that treat serious medical conditions and address unmet medical needs, while medicines continue to be evaluated in larger studies.
With FDA approval in hand, doctors can prescribe now the drug.
Rebecca Edelmayer, PhD, senior director of scientific engagement for the Alzheimer’s Association, says that with FDA’s move today, ramping up production — and eventually nationwide distribution and implementation — will take time.
“Ask your doctor about availability,” she says. “The main problem is that without insurance and Medicare coverage of this class of treatment, there is access for those who
could benefit from the newly approved treatment is only available to those who can pay out of pocket. Without coverage, people just won’t be able to get the treatment.”
the Washington Post reports that with the accelerated approval, drugmaker Eisai is expected to seek full FDA approval immediately, which is not expected to happen before the end of this year. Full approval could help clear the way for Medicare coverage of the drug.
Those who received Leqembi for 18 months in a clinical trial experienced a 27% less decline in memory and thinking compared to the group that received placebo. It also reduced brain amyloid, the sticky protein that builds up in the brains of people with Alzheimer’s and is thought to be a hallmark of the disease.
Howard Fillit, MD, co-founder and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation says, “It is the first Phase III study in our field with a disease-modifying drug where the clinical efficacy was very clear.”
Concerns about side effects
The drug has raised safety concerns as it has been linked to certain serious adverse events, including brain swelling and bleeding. In the study, 14% of patients received the drug experienced side effects these included brain swelling and bleeding, compared with about 11% in the placebo group.
Scientists have reportedly linked three together deaths during the lecanemab clinical trial, although it is unclear whether it caused the deaths.
Fillit notes that the first two people to die were on blood thinners when they were on lecanemab.
“There are things about the real-world use of the drug that we need to clarify, particularly in relation to people with comorbidities,” he says.
the third death is a little different, says Fillit. The patient who had a stroke showed signs of vasculitis, or inflammation of the blood vessels.
“We don’t know exactly what happened, but we do know that it was very, very rare,” he says.
Edelmayer says the most commonly reported side effects during the trials were infusion-related reactions, headache, and amyloid-related imaging abnormalities (ARIA). According to the FDA, these abnormalities are known to occur with antibodies of this class. ARIA is usually asymptomatic, although serious and life-threatening events can rarely occur.”
The FDA added these as warnings to the drug’s label, describing the potential infusion-related reactions as flu-like symptoms, nausea, vomiting, and changes in blood pressure.
How much will it cost?
Eisai says lecanemab will cost $26,500 per year.
In a draft report released in December, the Institute for Clinical and Economic Review (ICER) said a price between $8,500 and $20,600 a year would make the drug cost-effective. Although the group does not have the power to set prices, many major health insurers consider their reports when negotiating prices, and some drugmakers consider ICER’s recommendations when setting prices.
An editorial in The Lancet Last month warns that the cost will likely be “prohibitive” for low- and middle-income countries and many healthcare systems lack the infrastructure for widespread adoption.
Will Medicare cover it?
The Centers for Medicare and Medicaid Services (CMS), which operates Medicare, which covers most people with Alzheimer’s, has indicated that it will not have comprehensive coverage for amyloid-lowering drugs until the drug receives full U.S. approval based on clinical trials benefits, as opposed to expedited approval.
That means people would have to pay thousands out of pocket to get it first.
The CMS decision Medicare effectively denies coverage for fast-track FDA-approved drugs for Alzheimer’s disease unless the person is enrolled in an approved clinical trial.
On December 19, the Alzheimer’s Association filed formal request Request CMS to remove the trial-only requirement and provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments.
CMS says in an explanation Following today’s announcement, “As Eisai’s product, lecanemab, has received accelerated approval from the FDA, it falls under CMS’ existing determination of national coverage. CMS is reviewing the information available and may reconsider its current reporting based on this review.”
“If lecanemab subsequently receives traditional FDA approval, CMS would provide broader coverage,” the statement said.
Who will benefit most from this drug?
Lecanemab is a treatment for people with early-stage Alzheimer’s who have amyloid in their brain. This means that people with other types of dementia or people in later stages of Alzheimer’s disease are unlikely to see improvement with this drug.
Who makes lecanemab?
Japan-based Eisai is developing the drug, a monoclonal antibody, in collaboration with US company Biogen.
What is the Alzheimer’s Association’s view?
The association called for accelerated FDA approval. In an opinionit says it “welcomes and further encourages” the results of the clinical trial.
It says data published in the New England Journal of Medicine confirms that lecanemab “can significantly alter disease progression in people in the earliest stages of Alzheimer’s disease.”
“We are energized by the progress we are seeing in the research pipeline. Science tells us that while anti-amyloid treatments aren’t a cure, they won’t be the end
Treating Alzheimer’s — they’re certainly the beginning,” says Edelmayer.
Are there alternatives?
The FDA granted Biogen accelerated approval to manufacture another Alzheimer’s drug, Aduhelm (aducanemab), in 2021, but the move was controversial because the drug’s effectiveness was widely questioned. Since then it has largely been withdrawn from the market.
Aduhelm was the first approved early-stage Alzheimer’s treatment since 2003.