- A new Alzheimer’s drug, Leqembi, has received approval on July 7 from the Food and Drug Administration.
- The FDA approval comes after the medication showed promise in slowing cognitive decline in a phase 3 clinical trial.
- There are reports that three people died while taking the drug during the trial. The drug may also cause brain swelling and bleeding.
- Though Medicaid will cover a substantial portion of the cost of Leqembi, some experts have said Leqembi may reduce Alzheimer’s symptoms but not improve brain function.
On July 7, a new drug to treat Alzheimer’s disease received approval from the Food and Drug Administration (FDA).
The drug, lecanemab, will be sold under the brand name Leqembi.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Dr. Billy Dunn, the director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, in a press statement.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”
Some experts have questioned its effectiveness, but the medication showed promise in a phase 3 clinical trial.
Researchers said lecanemab slowed cognitive and functional decline by 27% when given to people with Alzheimer’s in the clinical trial.
However, the journal Science reported in late December that three people died while taking the drug during the clinical trial. The journal reports that the third death was a 79-year-old Florida woman who died in mid-September after developing brain swelling and bleeding.
Here’s everything you need to know about Leqembi as a potential treatment for Alzheimer’s disease.
Lecanemab was granted breakthrough therapy designation by the FDA in June 2021.
This status is designed to speed up the development of new drugs that will address medical needs that are currently unmet for serious or life-threatening conditions.
However, some scientists have expressed concern that the earlier phase 2 trials of lecanemab had flaws and that the actual benefit of the drug to people could be limited.
“The phase 2B lecanemab studies were fatally flawed because the high dose versus placebo analysis (that supposedly showed some clinical benefit) was profoundly compromised,” Dr. Michael Greicius, a professor of neurology and neurological sciences at Stanford University in California, told Healthline in an earlier interview.
Greicius argued that in the phase 2B trial, people who were carriers of APOE4, a type of gene associated with an increased risk of Alzheimer’s disease, were prevented midway through the trial from receiving a high dose of the treatment.
“This means that there were many more APOE4 carriers in the placebo group (71%) than in the high dose group (30%),” Greicius explained. “This difference in percentage of APOE4 carriers is as likely (or in my view more likely) than the drug to account for the difference in clinical outcomes.”
The recent clinical trial was conducted at 235 sites in North America, Asia, and Europe between March 2019 and March 2021.
The study involved nearly 1,800 adults ages 50 to 90. All the participants had some form of early dementia or Alzheimer’s disease. Half of the participants were given lecanemab and the other half were given a placebo.
Researchers reported there wasn’t a significant difference between lecanemab and the placebo at 12 months, but at 18 months it appeared the people taking lecanemab had some clearance of amyloid and less cognitive decline.
However, researchers said participants taking lecanemab had a higher percentage of adverse events than people taking the placebo at both 12 months and 18 months.
The Centers for Medicare and Medicaid Services announced they will provide significant coverage for Leqembi.
“CMS today affirms our commitment to help people with Alzheimer’s disease have timely access to innovative treatments that may lead to improved care and better outcomes,” CMS Administrator Chiquita Brooks-LaSure said in a statment.
“With FDA’s decision, CMS will cover this medication broadly while continuing to gather data that will help us understand how the drug works. This is welcome news for the millions of people in this country and their families who are affected by this debilitating disease.”
The CMS said that people with original Medicare plan will pay 20% coinsurance of the Medicare-approved amount after meeting their Part B deductible.