According to detailed data presented on Tuesday, an experimental Alzheimer’s drug from Eisai and Biogen slowed cognitive decline in a closely watched trial but may carry a risk of serious side effects for certain patients.

The drug, lecanemab, was linked to a dangerous type of brain swelling in nearly 13% of patients in the 18-month trial, which enrolled nearly 1,800 people with early-stage Alzheimer’s.

Some patients also experienced brain bleeding, with five experiencing macrohemorrhages and 14% experiencing microhemorrhages – a symptom linked to two deaths in a follow-up study.

In September, the companies announced that lecanemab, an antibody designed to remove sticky deposits of a protein called amyloid beta, reduced the rate of cognitive decline on a clinical dementia scale (CDR-SB) by 27% when compared to a placebo.

“All of these amyloid-lowering drugs carry a risk for increased brain hemorrhage,” said Dr. Ronald Petersen of the Mayo Clinic in Rochester, Minnesota. “I think the primary outcomes, the secondary outcomes, the amyloid-lowering is pretty impressive.”

The Alzheimer’s Association said the data shows the drug “can meaningfully change the course of the disease,” and it urged US regulators to approve the company’s accelerated approval application.

Eisai shares rose 3.6% in Tokyo afternoon trading, while Biogen shares rose 0.9% in after-hours trading. They have increased by 60% and 47%, respectively, since the trial’s preliminary findings were announced in late September.

Based on the CDR-SB measure, some patients with a genetic risk of developing the mind-wasting disease did not benefit from lecanemab.

They did, however, show improvement in the trial’s secondary goals, such as other cognition and daily function measures.

Overall, lecanemab patients outperformed placebo by 23% to 37% on these secondary trial goals.

“I believe it’s an important benefit that will justify full approval. But of course, we want a bigger benefit,” said Dr. Paul Aisen, director of the University of Southern California Alzheimer’s Therapeutic Research Institute and a co-author of the study published in the New England Journal of Medicine.

He believes lecanemab will be more effective if given earlier in the disease, “before you’ve accumulated enough irreversible damage to cause symptoms.”

The study’s detailed data was presented at the Clinical Trials on Alzheimer’s Disease meeting in San Francisco.

Eisai believes the trial results validate a long-held theory that removing amyloid beta from the brains of people with early Alzheimer’s can slow the disease’s progression.

According to Eisai, 68% of trial participants treated with lecanemab had amyloid clearance after 18 months. The drug also reduced tau levels, a different protein that forms toxic tangles within brain cells.

The two deaths from brain hemorrhages reported in the follow-up study were of a 65-year-old woman who received tissue plasminogen activator to clear blood clots after a stroke and an 87-year-old who was taking the blood thinner Eliquis.

According to Eisai, the deaths “cannot be attributed to lecanemab.”

Eisai’s U.S. chairman, Ivan Cheung, said in an interview that the company has protocols in place to monitor brain swelling and sees no need for restrictions on which patients may be eligible for lecanemab.

According to Dr. Howard Fillit, chief science officer at the Alzheimer’s Drug Discovery Foundation, doctors always weigh the advantages and disadvantages of therapies.

“Currently, I would hesitate to give this drug to someone on blood thinners,” he said.

The Food and Drug Administration is expected to decide by January 6 whether to approve lecanemab under its “accelerated” review program, which requires proof that a drug can influence a biomarker associated with a disease, such as amyloid beta reduction in the brain.

Regardless of that decision, Eisai plans to file for standard FDA approval of the drug soon, as well as approval in Europe and Japan, according to Cheung.

(Adapted from Businessworld.in)

Categories: Economy & Finance, Regulations & Legal, Strategy, Uncategorized