How the FDA-approved Alzheimer’s drug works and its possible side effects

How the FDA-approved Alzheimer’s drug works and its possible side effects

How the FDA-approved Alzheimer’s drug works and its possible side effects

Top line

On Friday, the FDA advanced the approval of Alzeihmer’s drug lecanemab (trade name Leqembi), but serious side effects and a death during a clinical trial possibly related to the drug have left many health professionals cautious in their optimism about a drug that could treat the disease, for for which there is no known cure.

Key facts

Report published in New England Journal of Medicine looked at a clinical trial of lekanemab and found that the drug was effective in slowing cognitive decline in some participants with the condition.

The study also found that cognitive decline was 27% slower over an 18-month period in those who took lekanemab compared to those who did not.

Lekanemab is made by drugmakers Biogen and Eisai and is intended to be administered intravenously every two weeks.

More than 55 million people worldwide suffer from dementia, and the majority (60-80%) suffer from Alzheimer’s disease, a progressive brain disease that slowly destroys memory and the ability to think.

There is no known cure for Alzheimer’s disease, but there are several FDA-approved medications that slow its progression and relieve symptoms, such as aducanumab (which slows progression) and rivastigmine (which treats symptoms).

Patients may have to wait before receiving the drug, as Medicare has pledged to extend any anti-amyloid drug to accelerated approval in clinical trials only after the controversial approval of the Alzheimer’s drug Aduhelm in 2021.

The bulk purchase cost of a 200mg vial is $254.81 and the cost of a 500mg vial is $637.07, with an estimated annual cost of around $26,500 according to Eisai.

How does drugemab work

According to Medical News Today, lekanemab is a monoclonal antibody: a lab-created antibody used to treat certain diseases, such as cancer and Alzheimer’s, and viruses such as Covid, by acting like antibodies produced by the body. Once introduced into the body, monoclonal antibodies are used to fight infection by acting like the human immune system. Neurons play a vital role in brain function, helping in areas such as communication and recovery. However, in the brains of Alzheimer’s patients, the neurons stop functioning and communicating with each other, eventually leading to their death. As a result, plaque forms (a buildup that forms when bits of protein stick together), which the National Institute on Aging can be very toxic to the brain. Lekanemab works by removing atherosclerotic plaque, slowing down the progression of the disease. “Lecanemab has been reported to be the most effective in removing amyloid plaques because it intervenes earlier in the pathological process that contributes to Alzheimer’s disease and has fewer side effects,” Dr. Karen D. Sullivan, a board-certified neuropsychologist, told Medical News Today.

Side effects

According New England Journal of Medicine In the study, around 17% experienced bleeding into the brain, compared with 9% of those who did not take the drug. Nearly 13% experienced cerebral edema, while only 2% of those in the control group who did not take drugemab experienced edema. Most of these incidents, however, were not serious and subsided within a few months. However, 3% of patients receiving druganemab developed more severe cerebral edema with symptoms such as confusion and visual disturbances. And 14% experienced serious side effects compared with 11% who did not take drugemab.

Possible death

A separate report published in New England Journal of Medicine on Wednesday detailed the death of a participant believed to be related to lekanemab. The participant – a 65-year-old man with the early stages of Alzheimer’s disease – was rushed to a hospital in Chicago when he showed signs of a stroke. The patient was treated with intravenous tissue plasminogen activator (t-PA) a clot-clearing drug, which is standard practice in the treatment of stroke, but was ultimately fatal. Scientists suspect that the combination of t-PA and lekanemab led to the patient’s death. “The extensive number and variability in the size of cerebral hemorrhages in this patient would be remarkable,” researchers from Northwestern University Feinberg School of Medicine in Chicago said in a report.

Critical quote

“Americans living with Alzheimer’s have a right to FDA-approved treatments, as do people with conditions like cancer, heart disease and HIV/AIDS,” Dr. Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement.

Further reading

Report gives new details on death possibly linked to experimental Alzheimer’s drug (CNN)

Lecanemab in early Alzheimer’s disease (New England Journal of Medicine)

FDA Approves Alzheimer’s Drug That Slowed Cognitive Decline in Clinical Trial (CNBC)

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