3 Unanswered Questions About Newly Approved Alzheimer’s Drug Rekembi

Newly Approved Alzheimer’s drug It will be available to patients in the coming days, according to its maker, Japanese pharmaceutical company Eisai.

The drug, called Leqembi, has been shown in clinical trials to slow the progression of Alzheimer’s disease in people with mild cognitive impairment or early-stage disease. It’s not a cure.

Leqembi targets a type of protein in the brain called beta-amyloid. Long Thoughts by Scientists one of the major causes of disease.

Administered as an intravenous drip every two weeks, it requires patients to visit a hospital or clinic twice a month for treatment. $26,500 per year.

Leqembi brings hope to patients and their families, but experts say there are still some important unanswered questions about the drug, including its safety and efficacy.

There are questions the experts still have about Leqembi.

Will the patient notice a difference?

Clinical trials found that Recambi slowed the progression of Alzheimer’s disease compared to a placebo, but experts called the drug’s effects “moderate” and whether it would make a noticeable difference in people’s daily lives. Unknown.

in medicine Phase 3 clinical trialresearchers looked at cognitive decline in about 1,800 people who received either the drug or a placebo over an 18-month period.

Cognitive decline is scale It focused on how well patients were doing in six areas: memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care.

For each category, patients are rated on a 5-point scale. 0 is normal, 0.5 is suspected dementia, 1, 2 and 3 are mild, moderate and severe stages of dementia, respectively.

Dr. Ronald Petersen, a neurologist at the Mayo Clinic in Rochester, Minnesota, says the assessment method is “very subjective.” That said, it’s currently the best method researchers have for quantifying the severity of a patient’s symptoms, he said.

The researchers summed up the scores to see how much they changed over the course of the trial in those given Rekembi compared to those given a placebo.

At 18 months, patients in the Leqembi group scored an average of 1.21 on the Clinical Dementia Scale and the placebo group scored 1.66, a difference of 0.45 or a 27% slower decline rate.

The difference is small, said Alberto Espey, Ph.D., a neurologist at the University of Cincinnati School of Medicine, and below the clinically meaningful threshold for patients.

Patients and their families are unlikely to be able to tell the difference, he concluded.

But Petersen had more hopes. “It doesn’t stop the disease, it doesn’t make it better, but it may slow its progression.

Who will benefit from Leqembi and for how long?

This group Approved for Patients Only People with mild cognitive decline or early stages of Alzheimer’s disease.

A sub-analysis of Eisai’s clinical trial data found that the drug appeared to be more effective in older than younger people and in men and women, primary care physician, Institute for Clinical and Economic Review, A group that determines fair prices for medicines.

“It makes me wonder if lecanemab is doing something that we haven’t fully figured out yet.”

More research is needed, said Donna Wilcock, associate dean of biomedicine at the University of Kentucky.

“Simply put, I’m not really sure why at this point,” she said. “We can speculate as to what that means, but ultimately the findings need to be further explored in additional studies.

Still, a sub-analysis should not be a reason not to offer Leqembi to a particular group, Wilcock said.

In addition to the question of who benefits most, there is also the question of how long the drug will benefit the patient.

Eisai’s Phase 3 results looked only at the effects of the drug over 18 months. Petersen said it’s unclear how effective the drug will be over the long term.

A 27% slowdown “could have a greater impact over 24, 36 and 48 months and be more meaningful in the future,” he said. I don’t think it’s really accurate to describe.”

Wilcock said many colleagues she spoke with were also “pretty confident” that the drug’s positive benefits would increase over time.

How safe is Rekembi?

According to the Food and Drug AdministrationLeqembi can cause cerebral hemorrhage or brain swelling — a side effect that researchers are particularly concerned about after 3 deaths reported Number of patients who got the medicine. In response to her first two death reports, Eisai denied her relationship with Leqembi.

According to Petersen, the cerebral hemorrhage and brain swelling are probably due to the drug’s action. Amyloid is removed from brain cells, but in the process it is also removed from the walls of blood vessels, potentially causing the brain to “leak.”

The side effects have also been seen with Biogen’s Aduhelm, another Alzheimer’s drug that also targets amyloid, Wilcock said.

Approximately 12.6% of patients who received Leqembi in clinical trials Brain swelling occurred compared to 1.7% in the placebo group. Approximately 17% of the Leqembi group experienced a cerebral hemorrhage compared to 9% of the placebo group.

The company said many people found to have brain swelling had no symptoms as a result.

Eisai’s Phase 3 trial lasted only 18 months, so it’s unclear how prevalent the condition is or if it becomes more common the longer people take the drug, Espay said. said.

Reports of cerebral hemorrhage and brain swelling “may be just the tip of the iceberg,” he said.

The symptoms “can be very serious,” Petersen said, adding that “there is no doubt about it.”

He said people infected with Leqembi should be closely monitored, but added that the side effects are manageable.

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