Not long after the controversial approval of Aduhelm, an expensive drug that claimed to provide some minimal relief for those with Alzheimer’s disease, another pharmaceutical combatant has entered the market. This drug claims better research results combined with an equally lofty price tag. But how well will the new drug, called Leqembi, actually work in real life? And what will be the impact on Medicare, which has offered conditional approval?
Articles about the FDA’s okay for Leqembi have been all over the press in the past several days. For this story on the Blog we took a look at a recent NBC News analysis done by health reporter Berkeley Lovelace. Lovelace’s story explains that Leqembi is the first approved drug to slow the progression of Alzheimer’s disease – but the new pharmaceutical weapon “will come with a strong safety warning about potentially life-threatening side effects.”
FDA Approval is a Controversial Step
Lovelace begins his NBC News story with the big headline: in a recent press release, the Food and Drug Administration announced that the agency had given its full approval for the Alzheimer’s drug Leqembi. This regulatory green light, says Lovelace, comes amid concerns about the drug’s safety, cost and accessibility.
“The move marks the first time that a drug meant to slow the progression of the disease has been granted full regulatory approval,” the story explains. “Other approved drugs only target its symptoms.” This is a potentially huge development for the 6.7 million U.S. adults ages 65 and older with Alzheimer’s disease, according to the Alzheimer’s Association.
Many Researchers Consider Drug a Significant Step
Many researchers expressed excitement over the approval of Leqembi and see the drug as an important step toward combatting Alzheimer’s disease. “I don’t think we can understate the significance of this moment,” said Donna Wilcock, the assistant dean of biomedicine at the University of Kentucky.
According to the NBC News report, Leqembi is jointly manufactured by Japanese drugmaker Eisai and U.S.-based drugmaker Biogen. The new compound “targets a type of protein in the brain called beta-amyloid, long thought by scientists to be one of the underlying causes of Alzheimer’s disease,” Lovelace explains.
The NBC News report cites a recent article in the New England Journal of Medicine describing a phase 3 clinical trial of 1,795 patients. All patients had what is described as mild cognitive impairment or early-stage disease. In the 18-month study, the progression of the illness or impairment was slowed by an average of 27 percent for those taking Leqembi.
Not a Cure – but a Hopeful Step
Experts quoted in the NBC News report agree that Leqembi is only a first step, but an encouraging one. Dr. Wilcock of the University of Kentucky told Lovelace that, “While patients still do decline on the drug, the decline is slowed.” That outcome appears to be a medical first.
Dr. Ronald Petersen, a Mayo Clinic neurologist, agreed. He told Lovelace in an email that Leqembi is not a cure, nor does it stop the disease. “It’s a first step for hopefully more therapeutics in the future,” he said.
“The Alzheimer’s Association, which has vocally advocated for the drug’s approval, praised the decision,” NBC News reports. The treatment could “give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love,” Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement. “This gives people more months of recognizing their spouse, children and grandchildren.”
Measuring How Leqembi Helps Alzheimer’s Patients
The NBC News report explains how researchers measured the effectiveness of the new drug. “In the phase 3 clinical trial, researchers measured cognitive decline using a scale that focused on how well patients performed in six categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care,” Lovelace said. For each category, patients were rated on a 5-point scale with 0 as normal, 0.5 considered “questionable,” and levels 1, 2 and 3 corresponding to mild, moderate and severe stages of dementia.
“Patients in the placebo group scored, on average, 1.66 on the scale after 18 months,” says the article. “Those who got Leqembi scored, on average, 1.21, a 0.45 difference or 27 percent slower rate of decline.” While this may seem minor, experts say the difference has real-life implications. Dr. Wilcock told NBC News that “this likely means more time for the patient to be living independently, enjoying their hobbies, their friends and having a better quality of life.” Wilcock said. “Time will tell how much, but the clinical trial did show significant benefit on activities of daily living measures.” The drug appeared to slow a patient’s decline for about five months.
Skeptics Point to Dangerous Side Effects
As the article warns, several experts in the field of Alzheimer’s research do not share their colleagues’ enthusiasm. One skeptic, University of Cincinnati neurologist Dr. Alberto Espay, told NBC News that most patients would not notice the scant 27 percent improvement.
What’s more, there are dangers of severe side effects. “The odds for brain swelling and hemorrhage are far higher than any actual improvement,” Dr. Espay said. He and other had launched a petition drive last month to persuade the FDA to deny Leqembi’s green light.
But the agency has apparently heeded those side effect warnings. “In its approval,” Lovelace reports, “the FDA included its strongest warning label — called a boxed warning — about these particular side effects, noting that they can lead to seizures and death. In addition, before starting the drug, patients should undergo genetic testing to better understand their risk for these side effects.”
Research trials showed brain swelling in about 12.6 percent of patients who got Leqembi compared with 1.7 percent of those in the placebo group. Those taking the drug were also about twice as likely to experience brain bleeds.
Who Will Be Able to Get Leqembi?
According to NBC News, Leqembi was approved for people with mild cognitive impairment or early-stage Alzheimer’s disease. The drug is given intravenously every two weeks, meaning patients will need to go to a hospital or clinic for the infusion. Experts also recommend periodic brain scans for Leqembi patients to monitor for any side effects.
Then there’s the question of cost. “Leqembi will carry a list price of $26,500 a year,” NBC News reports. Medicare plans to cover the drug, with stipulations.
“In June, the Centers for Medicare and Medicaid Services said it planned to provide coverage for Leqembi and other drugs in its class, contingent upon receiving full FDA approval,” says the report. “However, the agency said it will mandate that physicians gather real-world performance data on these medications through a government database. That means that only doctors who are willing to collect this data will be able to prescribe Leqembi.”
If patients are granted coverage, Medicare will cover 80 percent of the cost after applicable deductibles, leaving patients responsible for the remaining 20 percent. That can easily mean out-of-pocket costs of several thousand dollars, rendering Leqembi unaffordable for many.
What about Aduhelm, the drug with which Leqembi is often compared? It was granted accelerated FDA approval in 2021 but the action was highly controversial. An 18-month Congressional investigation found that the approval of Aduhelm was “rife with irregularities,” putting the agency under further scrutiny. Adding to the brouhaha was the stratospheric cost of Aduhelm, initially pegged at $56,000 a year but later slashed in half by maker Biogen.
“With only accelerated approval, the drug is only covered by Medicare if people are enrolled in a clinical trial,” NBC News reports. “No date has been set on when the FDA could make a decision on Aduhelm’s full approval.”
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(originally reported at www.nbcnews.com)