The breakthrough Alzheimer's drug Leqembi slowed the progression of the disease in patients over three years, highlighting the necessity for long-term treatment, in keeping with recent data released Tuesday by Japanese pharmaceutical company Eisai.
The study results on Leqembi, which Eisai Biogenalso found that a patient's Alzheimer's disease worsened after stopping treatment. The incidence of adversarial events related to Leqembi, including brain bleeding and swelling, decreased after six months of treatment, Dr. Lynn Kramer, Eisai's chief clinical officer for advanced human biology studies, told CNBC.
This decline is critical: These brain uncomfortable side effects have raised concerns amongst some doctors and are the essential reason why a European drug regulator advised against approving Leqembi last week.
The study accommodates the longest data available thus far on the efficacy and safety of Leqembi, whose launch within the US has been bumpy since approval last summer because of bottlenecks related to diagnostic testing requirements and regular brain scans, amongst other things. Eisai published 24-month data to the letter in November.
Eisai presented the outcomes on Tuesday in Alzheimer's Association International Conference in Philadelphia, the world's largest meeting for dementia research. The results provide a primary glimpse of what the longer term of Alzheimer's patients might appear like with therapies akin to Leqembi, which is currently administered twice a month by infusion.
The drug is a monoclonal antibody that targets toxic plaques within the brain called amyloid, an indicator of Alzheimer's disease, and is designed to slow the progression of the disease in its early stages. Leqembi also works by eliminating protofibrils, the constructing blocks of amyloid plaques.
The data underscore the importance of early and sustained treatment for people living with this notoriously difficult-to-treat brain disease – even after a drug has cleared a patient’s amyloid plaques.
“Continued treatment is important if you want to maintain your cognitive abilities and functionality for longer,” Kramer said.
Although Leqembi is just not a cure, “if you start early enough, it can benefit you for years,” he said.
Kramer added that Eisai expects that patients will eventually have the opportunity to modify to a maintenance dose of Leqembi after roughly 18 to 24 months of treatment, which might allow less frequent or more convenient approach to take the drugs over an extended time period.
Eisai and Biogen are searching for regulatory approval for a once-monthly infusion of Leqembi, with a choice expected in January. The drugmakers also plan to launch an injectable type of Leqembi that patients can take once per week at home.
“These two things will change the paradigm, make it easier for the patient, make it easier for the entire medical system,” Kramer said in an interview.
Nearly 7 million Americans have the condition that fifth leading reason for death for adults over 65, in keeping with the Alzheimer's Association. By 2050, the variety of Alzheimer's patients within the United States is predicted to rise to almost 13 million
Details of the long-term study
The results are based on extensive research on chosen participants in mid- and late-stage Leqembi studies.
A phase three study called Clarity AD studied three different groups of patients for 36 months.
One group of participants took Leqembi for 3 years, while one other group received a placebo for the primary 18 months before switching to Eisai's drug for a similar duration. Eisai monitored a final group of patients outside the study who received no treatment for 3 years.
Patients who began treatment with Leqembi early continued to profit from the drug over three years and showed slower cognitive decline in comparison with the opposite two groups, in keeping with a presentation by Eisai.
According to Kramer, the difference in cognitive decline between the “early onset” Leqembi group and people who received nothing throughout the study period became larger between 18 and 36 months.
Leqembi “interrupts the natural course of the disease and has an increasingly powerful effect,” he said, adding: “The earlier you detect the disease, the better.”
Patients who began on a placebo experienced slower cognitive decline after they switched to Leqembi after 18 months, but their Alzheimer's disease was still worse than within the group that took Leqembi earlier within the 36-month period.
A sub-study of the study checked out patients who had no or very low levels of one other protein called tau, which accumulates within the brain and is taken into account a marker of the severity of Alzheimer's disease. People with low levels of this protein are within the early stages of the disease.
After three years of taking Leqembi, 59 percent of individuals with no or very low tau levels showed no progress in any respect of their Alzheimer's disease, the presentation said. Just over half of those patients actually saw their condition improve.
A Phase 2 study called Study 201 has now examined patients who temporarily stopped treatment with Leqembi.
For 18 months, one group of participants took Leqembi and the opposite group took a placebo. The groups then took nothing for a median of two years before all patients began treatment with Leqembi for an additional 18 months.
The positive effect of Leqembi on a patient's disease was maintained even after treatment was stopped, the presentation said.
But the speed of cognitive decline in patients who stopped taking Leqembi returned to the speed in individuals who took a placebo throughout the break, showing that the disease continues to progress even when amyloid plaques are removed and a patient stops taking Leqembi, Eisai said in a news release.
“The idea is: If you stop, you’ll get worse,” Kramer said.
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