FDA’s approval of Lequembi is met with hesitation

The Food and Drug Administration (FDA) approved a new Alzheimer’s drug, Leqembi (lecanemab-irmb), on Jan. 6, 2023. Eisai, a Japanese pharmaceutical company, found that the drug helps slow cognitive decline by 27% over 18 months.

Leqembi targets the beta-amyloid, the protein scientists have long thought to be one of the leading causes of the disease. Eisai estimates that roughly 100,000 Americans suffering from the early stages of Alzheimer’s will be found eligible for Leqembi in about three years. About 2.5 million people globally will be qualified by 2030.

Leqembi, approved under the FDA’s Accelerated Approval pathway, is an expedited authorization program for drugs targeted toward severe conditions with limited medical treatments.

The drug’s Phase 3 clinical trial was conducted through a double-blind, placebo-controlled study of 856 patients with early-stage Alzheimer’s disease. The trial demonstrated that Leqembi slowed down the progression of Alzheimer’s disease compared to a placebo.

“The double-blind aspect is important to control as well to ensure that the researchers who collect the data do not say anything that would bias the participants,” AP Psychology teacher Sharon Vires said. “The sample is relatively large, which also contributes to the high level of validity.”

However, experts have called the drug’s effect “modest,” It is still unclear whether it will lead to substantial changes in people’s daily lives. This speculation comes from the 0.45 difference in scores on the dementia scale following the study between test groups.

According to the FDA, the drug can lead to brain bleeding and swelling. These side effects are a cause of concern as there are reports of three deaths of patients who took the pill. Eisai has denied a link to Leqembi concerning the first two deaths. Other side effects include amyloid-related imaging abnormalities (ARIA), which can lead to a “leaky” brain and flu-like symptoms. The FDA advised that Leqembi patients should be monitored closely but added that the side effects should be manageable.

“It is unlikely that patients or their families would be able to tell the difference,” Dr. Alberto Espay, a neurologist at the University of Cincinnati College of Medicine, said in an interview with NBC. “It doesn’t stop the disease, it doesn’t make it any better, but it might delay the rate of progression.”

Leqembi is said to be safer than the other leading Alzheimer’s treatment, Aduhelm. Both drugs have been shown to cause brain swelling and bleeding, with the risk Leqembi presents being slightly less. Leqembi costs $26,500 annually, somewhat cheaper than Aduhlem, which costs $28,2000 annually.

The Centers for Medicare and Medicaid Services (CMS) announced that they would not cover the cost of Leqembi until it receives full FDA approval. The CMS said it would consider changing the policy when the FDA gets the results from the phase three studies. Eisai provided the data to the FDA on the same day the drug received accelerated approval.

“Because of these unprecedented and unnecessary CMS and coverage obstacles, people are losing the opportunity to discuss with their healthcare providers and their families if this treatment is right for them,” Chief Science Officer at the Alzheimer’s Association, Dr. Maria Carrillo, said in an interview with Verywell.

“I was excited to first hear about the approval of this new drug. But I feel the FDA may have rushed its approval, as I am worried about the drug’s safety,” Richard Montgomery sophomore Libby Cooke said.

The FDA’s approval of Leqembi, the second-ever drug to reduce cognitive decline in patients with Alzheimer’s, was initially met with optimism. However, since the announcement, many Alzheimer’s researchers have expressed concerns over the drug’s safety, leaving the drug’s future success unclear.

Written by Shelby Roth of Richard Montgomery High School

Photo courtesy of Andrew Brookes/Getty Images