Leqembi, the new FDA-approved Alzheimer’s disease treatment, is prepared Tuesday, Nov. 7, 2023, at Abington Neurology Associates in Abington, Pa.
Hannah Yoon | The Washington Post | Getty Images
Japanese drugmaker Eisai released new data on Tuesday showing that its breakthrough Alzheimer’s drug Leqembi slowed the progression of the disease in patients over three years, suggesting they need to stick with treatment long-term.
The Leqembi research results shared by Eisai Biogenalso found that patients’ Alzheimer’s disease worsened after treatment was stopped. Dr. Lynn Kramer, chief clinical officer at Eisai Deep Human Biology, told CNBC that the incidence of adverse side effects associated with Leqembi, including brain bleeding and swelling, decreased after six months of treatment.
The drop is crucial: These brain side effects have worried some doctors and were the main reason Europe’s drug regulator last week recommended against approving Leqembi.
The study represents the longest efficacy and safety data yet for Leqembi, which has had a bumpy rollout in the U.S. since it won regulatory approval last summer due to bottlenecks such as diagnostic testing requirements and regular brain scans. Released by Eisai 24 months data Letter about November.
Eisai on Tuesday Alzheimer’s Disease Association International Conference In Philadelphia, the world’s largest dementia research conference. The results provide a first look at the future for Alzheimer’s patients receiving treatments such as Leqembi, which is currently taken as a twice-monthly infusion.
The drug is a monoclonal antibody that targets toxic plaques in the brain called amyloid, a hallmark of Alzheimer’s, to slow the progression of the disease in its early stages. Leqembi also removes fibrils, the building blocks of amyloid plaques.
These data illustrate the importance of early and continued treatment for people with a brain disease that is notoriously difficult to treat, even if the drug clears a patient’s amyloid plaques.
“Continuing treatment is important if you want to maintain cognition and function longer,” Kramer said.
While Leqembi is not a cure, “if you start early, it can give you years of benefits,” he says.
Kramer added that Eisai believes that after approximately 18 to 24 months of treatment, patients can eventually be switched to a maintenance dose of Leqembi, which could be a Less frequent or more convenient methods of taking medications long-term.
Eisai and Biogen are seeking regulatory approval for the once-monthly injection Leqembi, with a decision expected in January. The drug company also plans to bring to market an injectable form of Leqembi that patients can take at home once a week.
“Those two things are going to change the paradigm and make it easier for patients and make it easier for the entire health care system,” Cramer said in an interview.
almost 7 million Americans have this condition, fifth leading cause of death For adults 65 and older, according to the Alzheimer’s Association. The number of people living with Alzheimer’s disease in the United States is expected to increase to nearly 13 million by 2050
Long term study details
The results are based on an extended study of certain participants in the mid-stage and late-stage trials of Leqembi.
A phase 3 trial called Clarity AD examined three different groups of patients for 36 months.
One group of participants took Leqembi for a full three years, while another group took a placebo for the first 18 months and then switched to Eisai’s drug for the same period of time. Eisai looked at a final group of patients outside the trial who did not receive any treatment for three years.
Tek Image/science Photo Library | Science Photo Library | Getty Images
According to Eisai, patients who started Leqembi early continued to benefit from the drug for three years, experiencing slower cognitive decline than the other two groups.
Kramer said the difference in cognitive decline between the “early start” Leqembi group and those who did not receive any treatment throughout the study became larger between 18 and 36 months.
Leqembi “blocks the natural progression of the disease with increasing impact,” he said, adding that “the earlier it is detected, the better.”
Patients who started taking placebo experienced slower cognitive decline when they switched to Leqembi 18 months later. But at 36 months, their Alzheimer’s disease was still more severe than in the group who started Leqembi earlier.
A substudy part of the trial examined patients with no or very low levels of another protein called tau in their brains, which is thought to be a marker of Alzheimer’s disease severity. People with lower levels of this protein are in the early stages of the disease.
According to reports, after three years of using Leqembi, 59% of people with no or very low tau levels saw no progression of Alzheimer’s disease at all. More than half of patients actually improved.
Meanwhile, a phase 2 trial called Study 201 examined patients who temporarily stopped treatment with Leqembi.
For 18 months, one group of participants took Leqembi, while the other group took a placebo. Each group then took no medication for an average of two years before all patients began another 18 months of Leqembi treatment.
According to reports, Leqembi’s positive effect on the patient’s disease remains even if the patient stops treatment.
But the rate of cognitive decline in patients who stopped Leqembi returned to the rate of those who took a placebo during the interval. This shows that even if amyloid plaques are removed, the disease continues to progress when patients stop Leqembi, Eisai said in a news release.
“The concept is that if you stop, you’ll get worse,” Kramer said.
About The Author
