Alzheimer’s drug lecanemab gets accelerated approval amid safety concerns – Boston News, Weather, Sports

(CNN) — The U.S. Food and Drug Administration on Friday granted accelerated approval for the Alzheimer’s drug lecanemab, one of the first experimental dementia drugs that appears to slow the progression of cognitive decline.

“Alzheimer’s disease immeasurably impacts the lives of those who suffer from it and has a devastating impact on their loved ones,” said Dr. Billy Dunn, director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research an explanation. “This treatment option is the latest therapy that targets and affects the underlying disease process of Alzheimer’s rather than just treating the symptoms of the disease.”

Lecanemab will be marketed as Leqembi, the FDA statement said. It has shown “potential” as a treatment for Alzheimer’s disease by appearing to slow its progression, according to the results of the phase 3 study, but it has raised safety concerns due to its association with certain serious adverse events, including brain swelling and bleeding.

In July, the FDA accepted Eisai’s biologics license application for lecanemab under accelerated approval and granted drug priority review, the company said. the accelerated admissions program allows for earlier approval of drugs that treat serious conditions and “meet an unmet medical need” while the drugs continue to be studied in larger and longer trials.

If these studies confirm that the drug offers clinical benefit, the FDA could grant traditional approval. But if the confirmatory study doesn’t show a benefit, the FDA has the regulatory procedures in place that could result in the drug being withdrawn from the market.

What is known about lecanemab?

Lecanemab, a monoclonal antibody, is not a cure but works by binding to amyloid beta, a hallmark of Alzheimer’s disease. Results of an 18-month phase 3 clinical study were published in late November The New England Journal of Medicine showed that lecanemab “reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline in cognition and function than placebo at 18 months, but was associated with adverse events.”

The results also showed that about 6.9% of study participants who received lecanemab by intravenous infusion discontinued the study due to side effects, compared with 2.9% of participants who received placebo. Overall, serious adverse events occurred in 14% of the lecanemab group and 11.3% of the placebo group.

The most common adverse events in the lecanemab group were reactions to the intravenous infusions and abnormalities in their MRIs, such as B. brain swelling and bleeding, called amyloid-related imaging abnormalities or ARIA, which can become life-threatening.

Some people who get ARIA may not have any symptoms, but it can occasionally lead to hospitalization or permanent disability. And the frequency of ARIA appeared to be higher in people who had a gene called APOE4, which can increase the risk of Alzheimer’s or other dementias. ARIA “were numerically less common” among APOE4 non-carriers, the study showed.

The drug’s prescribing information includes a warning about ARIA, the FDA says.

The study results also showed that around 0.7% of the participants in the lecanemab group and 0.8% of the participants in the placebo group died, which corresponds to six deaths in the lecanemab group and seven in the placebo group.

The Alzheimer’s Association welcomed Friday’s decision.

“By slowing disease progression when taken in the early stages of Alzheimer’s disease, individuals will have more time to participate in daily life and live independently,” said President and CEO Joanne Pike. “This could mean more months to acknowledge her spouse, children and grandchildren. It could also mean that a person has more time to drive safely and accurately and to promptly attend to family finances and fully participate in hobbies and interests.”

According to this, more than 6.5 million people in the United States are living with Alzheimer’s disease Alzheimer Societyand that number is projected to grow to 13.8 million by 2060.

Will Medicare cover it?

Lecanemab will have a wholesale price of $26,500 per patient per year, the drug’s makers announced Friday.

Biogen and Eisai listed the drug slightly below the discounted price of Alzheimer’s drug Aduhelm, which now costs the average patient about $28,200. The companies were forced to lower the cost of Aduhelm – originally set at $56,000 per patient per year – after insurers refused to cover the cost.

To justify the cost of Leqembi, the companies said in a press release that, based on the estimated quality of life of the people who take it, the drug’s value to society is about $37,000 per year, but they chose to go down “to encourage broader patient access, reduce the overall financial burden and support the health sustainability of the system.”

The wholesale cost of a drug is comparable to the sticker price of a car. It’s not necessarily what patients pay after insurance or other discounts are factored in.

However, there is no insurance coverage for this drug. Medicare restricted coverage for lecanemab’s sister drug, Aduhelm, after clinical trials showed questionable benefits for patients. The agency agreed to only adopt the drug for people participating in registered clinical trials, limiting access to the drug.

Chiquita Brooks-LaSure, administrator of the Center for Medicare and Medicaid Services, said after the FDA’s decision Friday that her office would review Leqembi quickly, but for now it will be treated the same as Aduhelm due to its expedited approval.

“At CMS, we will continue to expeditiously review data on these products as they become available and are committed to timely access to treatments, including medicines, that improve clinically meaningful outcomes,” Brooks-LaSure said an explanation.

Last month, the Alzheimer’s Association filed a formal application requesting that CMS provide “full and unrestricted coverage” of FDA-approved Alzheimer’s treatments.

“What the FDA did today by granting Leqembi an accelerated approval was the right decision. But what CMS is doing by severely reducing coverage for approved treatments is unprecedented and wrong,” Pike said in a statement Friday.

“The FDA carefully reviewed the evidence for Leqembi before granting approval. In sharp contrast, CMS denied reporting on Leqembi months ago, before it even reviewed the evidence supporting that drug. CMS has never done this with any drug before, and it’s clearly harmful and unfair to people with Alzheimer’s. Without access to and coverage of this treatment and others in its class, people lose days, weeks, months – memories, skills and independence. You lose time.”

CMS told CNN that it would review and respond to the association’s request. The agency also noted that it continues to stay informed of ongoing clinical trials, including the latest results of lecanemab published in the New England Journal of Medicine. It has also met with drug manufacturers to learn more about their efforts since the CMS coverage decision was announced.

The FDA approved Aduhelm for early-stage Alzheimer’s disease in 2021 – but that decision has been debated as controversial Congressional investigation took place last week that the FDA’s “atypical collaboration” in approving the high-priced drug was “riddled with irregularities.”

Prior to Aduhelm, the FDA had not approved a novel therapy for the condition since 2003.

Aduhelm’s FDA approval and initially high price tag hit Medicare’s Part B premiums, increasing standard monthly payments for 2022 by 14.5% to $170.10.

About $10 of the premium increase — or just under half that amount — was attributable to Aduhelm, a CMS official told CNN in late 2021.

The premium increase was set before Medicare announced its limited coverage for the drug, but its actuaries had to ensure the program had adequate funding if Aduhelm was covered.

Medicare’s decision, along with Biogen’s reduction in the cost of the drug, caused monthly premiums for 2023 to drop to $164.90.

“This drug is not for everyone”

The FDA’s accelerated approval of lecanemab was expected, said Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic at the Center for Brain Health at Schmidt College of Medicine at Florida Atlantic University.

Isaacson said lecanemab could be “another tool” in his toolbox to help fight Alzheimer’s disease.

“I will prescribe this drug to the right person, at the right dose, and in a very carefully monitored manner, but this drug is not for everyone,” he said.

“I would do a genetic test for APOE4 first. I would have an open conversation with my patients,” he said. “If someone has side effects, if someone is taking a blood thinning medication, if someone has a problem, they need to discuss it with the treating doctor and see a doctor right away.”

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Sarah Y. Kim

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