Alzheimer: According to fresh data released on Tuesday, an experimental Alzheimer’s disease treatment from Eisai and Biogen halted cognitive decline in a widely watched trial but may pose a risk of dangerous side effects for certain patients.
In 12.6 percent of trial patients, the medicine, lecanemab, was related with a form of brain swelling, a side effect previously identified with similar drugs. In a follow-up study, 14 percent of patients developed microhemorrhages in the brain, a symptom connected to two recent fatalities of people receiving lecanemab, and five patients had macrohemorrhages.
The firms announced in September that the 18-month research, which involved over 1,800 people with early-stage Alzheimer’s disease, discovered that therapy with lecanemab lowered the rate of decline on a clinical dementia scale (CDR-SB) by 27% compared to a placebo.
Dr. Ronald Petersen of the Mayo Clinic in Rochester, Minnesota said, “All of these amyloid-lowering drugs carry a risk for increased brain hemorrhage. “I think the primary outcomes, the secondary outcomes, the amyloid-lowering is pretty impressive.”
What does the evidence reveals?
The Alzheimer’s Association said the evidence shows the treatment “can profoundly affect the course of the disease for those in the earliest stages of Alzheimer’s disease,” and it urged US regulators to approve the company’s fast approval application.
Eisai shares were up 3% in Tokyo Wednesday morning, while Biogen shares were up 0.9 percent in after-hours trading. They have increased by 60% and 47%, respectively, since the trial’s preliminary findings were announced in late September.
The Alzheimer’s Association said the evidence shows the treatment “can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease,” and it urged US regulators to approve the company’s fast approval application.
Eisai shares were up 3% in Tokyo Wednesday morning, while Biogen shares were up 0.9 percent in after-hours trading. They have increased by 60% and 47%, respectively, since the trial’s preliminary findings were announced in late September.
The trial found no advantage on the CDR-SB measure for some patients who were genetically predisposed to the mind-wasting condition.
Approximately 16% of participants had two copies (homozygous) of the APOE4 gene mutation known to increase the risk of developing Alzheimer’s, 53% had one copy (heterozygous), and 31% were noncarriers.
“For that small group of homozygous patients, when it comes to CDR-SB we don’t see a signal favoring lecanemab,” Eisai’s US chairman, Ivan Cheung, said in an interview. He speculated that this could be because homozygous trial patients given a placebo performed better than expected.
Secondary aims of the research, such as additional measures of cognition and everyday function, were met by APOE4 carriers. On these secondary trial aims, lecanemab patients improved by 23% to 37% when compared to a placebo.
“I believe it’s an important benefit that will justify full approval. But of course, we want a bigger benefit,” said Dr. Paul Aisen, head of the Alzheimer’s Therapeutic Research Institute at the University of Southern California and a co-author of the study published in the New England Journal of Medicine. He believes lecanemab will be more effective if administered early in the disease, “before you’ve accumulated enough permanent damage to cause symptoms.”
The study’s detailed data was presented at the Clinical Trials on Alzheimer’s Disease symposium in San Francisco.
Also Read: No Twitter on iPhone? Allen makes a significant claim regarding Apple
Evidence of Amyloid theory
Eisai believes the trial results validate a long-held notion that removing sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer’s can slow the disease’s progression.
Eisai reported that at 18 months, 68 percent of study participants treated with lecanemab had amyloid clearance.
Two deaths have been reported among trial extension participants, both from cerebral haemorrhages: a 65-year-old lady who got tissue plasminogen activator to clear blood clots after having a stroke and an 87-year-old who was on the blood thinner Eliquis.
According to Eisai, the two deaths “cannot be related to lecanemab.”
Cheung stated that Eisai has standards in place to monitor brain swelling and believes there is no need to limit which patients may be eligible for lecanemab treatment.
According to Dr. Howard Fillit, chief science officer at the Alzheimer’s Drug Discovery Foundation, doctors routinely weigh the advantages and disadvantages of therapy. “Currently, I would hesitate to give this drug to someone on blood thinners,” he stated.
The Food and Medicine Administration is expected to decide by January 6 whether to approve lecanemab under its “accelerated” review method, which needs confirmation that a drug can influence a biomarker associated with a condition, such as amyloid beta decrease in the brain.
Regardless of that decision, Eisai aims to petition for normal FDA clearance of the medicine soon, as well as approval in Europe and Japan, according to Cheung.
Keep watching our YouTube Channel ‘DNP INDIA’. Also, please subscribe and follow us on FACEBOOK, INSTAGRAM, and TWITTER
