January 6, 2023 – The highly anticipated Alzheimer’s drug lecanemab is grant accelerated approvalThis afternoon’s approval of tatus by the FDA offers hope to patients and their families affected by this devastating disease.
More than 6 million people in the United States are living with Alzheimer’s disease.
It’s not a cure, but this IV every 2 weeks has shown Moderately positive clinical impact Trials to slow early disease.
But many are cautious.As explained in a magazine editorial last month Lancet“The Alzheimer’s community has become accustomed to false hopes, disappointments, and controversy.”
Some people are concerned about the safety of lecanemab because some people in clinical trials have experienced serious side effects of bleeding and swelling in the brain.scientists recently third death lecanemab, brand name Leqembi, although the drugmaker dispute Drugs are the cause.
So what should patients and their families think of today’s news? Here, we answer some of the hottest questions surrounding the drug.
What does today’s FDA action mean?
The FDA granted accelerated approval to Leqembi after it showed positive trial results in slowing early disease progression.
FDA may grant accelerated approval For medicines that treat serious diseases and address unmet medical needs, while continuing to study medicines in larger trials.
With FDA approval, doctors can now open drug.
Rebecca Edelmayer, Ph.D., senior director of scientific engagement for the Alzheimer’s Association, said that with today’s action by the FDA, it will take some time to speed up production — and eventually national distribution and implementation.
“Ask your doctor about availability,” she says. “The main problem is that without insurance and health insurance coverage for such treatment, those
Patients who can benefit from the newly approved treatment will only be available to those who are able to pay out of pocket. Without insurance, people simply cannot get treatment. “
This Washington post With approvals accelerating, drugmaker Eisai is expected to file for full FDA approval immediately, which is unlikely to happen before later this year, the report said. Full approval could help clear the way for Medicare coverage of the drug.
People who took Leqembi for 18 months in a clinical trial experienced a 27 percent reduction in decline in memory and thinking compared to the group given a placebo. It also reduced brain amyloid, a sticky protein that accumulates in the brains of Alzheimer’s patients and is considered a hallmark of the disease.
“This is the first Phase III study of a disease-modifying drug with very clear clinical efficacy in our field,” said Howard Fillit, MD, co-founder and chief scientific officer of the Alzheimer’s Drug Discovery Foundation.
concerns about side effects
The drug has raised safety concerns because it has been linked to certain serious adverse events, including brain swelling and bleeding. In the trial, 14 percent of patients who received the drug experienced side effects These included brain swelling and bleeding, compared with about 11 percent in the placebo group.
According to reports, the scientists combined three death toll During clinical trials of lecanemab, though it is unclear whether it caused the deaths.
Fillit noted that the first two patients who died were taking blood thinners while receiving lecanemab.
“We need to address some of the issues with drug use in the real world, especially in the case of people with comorbidities,” he said.
This third death It’s a little different, Fillit said. Stroke patients show signs of vasculitis, or inflammation of blood vessels.
“We don’t know exactly what’s going on, but we know it’s very, very rare in the people who were involved in the trial,” he said.
The most common side effects reported during the trial were infusion-related reactions, headaches and amyloid-related imaging abnormalities (ARIAs), Edelmayer said. According to the FDA, these abnormalities “are known to occur in this class of antibodies. ARIA is usually asymptomatic, but serious and life-threatening events rarely occur.”
The FDA has added these as warnings to drug labels, describing possible 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) Indicates prices ranging from $8,500 to $20,600 One year would make the drug cost-effective. While the organization does not have the authority to set prices, many large health insurers consider its reports when negotiating prices, and some drugmakers consider ICER’s recommendations when setting prices.
an editorial Lancet It warned last month that costs could be “prohibitive” for low- and middle-income countries, and that many health systems do not have the infrastructure for widespread rollout.
Will Medicare cover it?
The Centers for Medicare and Medicaid Services (CMS), which runs Medicare that covers most Alzheimer’s patients, said it would not broadly cover amyloid-lowering until the drug is fully approved in the U.S. based on clinical benefit Drugs, not accelerated approval.
That means people have to pay thousands of dollars out of pocket to get it in the first place.
CMS decision Effectively denying Medicare coverage for FDA-approved fast-track drugs for Alzheimer’s disease unless the person is enrolled in an approved clinical trial.
On December 19, the Alzheimer’s Association submitted a formal request Requires CMS to remove the trial-only requirement and provide comprehensive and unlimited coverage for FDA-approved Alzheimer’s treatments.
CMS says a statement Following today’s announcement: “As Eisai’s product, lecanemab, received accelerated FDA approval, it falls under CMS’s existing national coverage determination. CMS is reviewing available information and may reconsider its current coverage in light of this review. “
“Should lecanemab subsequently receive traditional FDA approval, CMS would provide broader coverage,” the statement said.
Who benefits the most from this drug?
Lecanemab is a drug that treats people with early-stage Alzheimer’s disease who have amyloid in their brains. This means that people with other types of dementia or those in advanced stages of Alzheimer’s disease are less likely to improve with this drug.
Who makes Lecanemab?
Japan-based Eisai is working with US company Biogen to develop the monoclonal antibody drug.
What is the Alzheimer’s Association’s view?
The association urged accelerated FDA approval. in a statementwhich said it “welcomes and further encourages” the clinical trial results.
It says the data is published in New England Journal of Medicine demonstrated that lecanemab “can meaningfully alter the course of Alzheimer’s disease in people in the early stages of Alzheimer’s disease.”
“We are energized by the progress we are seeing in our research pipeline. The science tells us that while anti-amyloid treatments are not a cure – they are not over
Treating Alzheimer’s disease — they’re definitely the beginning,” Edelmayer said.
Are there alternatives?
The FDA granted accelerated approval to Biogen to make another Alzheimer’s drug, Aduhelm (aducanemab), in 2021, but the move has been controversial because the drug’s effectiveness has been widely questioned. It has since been largely withdrawn from the market.
Aduhelm is the first approved early-stage Alzheimer’s treatment since 2003.