A breakthrough drug slows Alzheimer’s progression in major clinical trial
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Lecanemab, a drug developed by the Japanese pharmaceutical company, Eisai Co. Ltd has shown promising results in a clinical trial by slowing cognitive decline in Alzheimer's patients who received it, Bloomberg reported. This is the first drug to blunt the progression of the symptom in the final-phase trial so far.
Tokyo-based Eisai has developed the drug with Massachusetts-based Biogen Inc. and is the second drug the collaboration has developed to lower amyloid, a toxic protein that is found in the brains of patients with Alzheimer's disease.
Multiple pharmaceutical companies have attempted to develop drugs that can reduce amyloid in the brain. However, clinical trials, including one for Aduhelm, developed by Eisai and Biogen, have produced mixed results.
How are the results of this trial different?
The study conducted at sites in Japan, China, Europe, and the U.S. included 1,795 participants with mild cognitive impairment due to Alzheimer's disease (AD). The presence of amyloid plaques was confirmed in all participants.
Participants in the study were allocated in 1:1 ratio to receive either the placebo or the drug, lecanemab. Patients in the treatment group were bi-weekly administered 10mg of each kg of body weight for a period of 18 months.
When compared on a common rating scale, the drug-treated group was observed to have slowed cognitive decline in the patients by 27 percent, also compared to the placebo group, a company press release claimed.
This is not only a significant result, but it also confirms the amyloid hypothesis for the disease progression that has come under lens after years of failed trials.
When will the drug be available?
Lecanemab is a monoclonal antibody that binds to neutralize and eliminate the amyloid-beta aggregates in the brain. In addition to meeting the primary endpoint of slowing cognitive decline, the drug also met secondary endpoints of the trial such as the change in amyloid levels from baseline at 18 months in the placebo group and several measures of cognitive impairment.
The treatment is not without some serious side effects, though. About 21 percent of the patients that received the drug experienced brain swelling or bleeding during the course of the treatment. Nealy three percent of the patients had symptomatic swelling. In comparison, only nine percent of the patients in the placebo group experienced similar symptoms.
In the U.S., the drug is already being considered by regulators for accelerated approval, and with the newly available data, the companies will now seek full Food and Drug Administration (FDA) approval for the drug by March 2023. This will also make the drug available under broad insurance coverage, making it accessible to large sets of people.
Prior to doing that, the full results of the study are expected to be published at a medical conference next month, following which a scientific publication is also expected, Bloomberg said in its report.
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