�������ýҕ�l

The experimental drug lecanemab shows “potential” as an Alzheimer’s disease treatment, according to new Phase 3 trial results, but the findings raise some safety concerns because of its association with certain serious adverse events. Lecanemab has become one of the first experimental dementia drugs to appear to slow the progression of cognitive decline. (Howard, 11/30)

The drug, lecanemab, slowed the cognitive and functional decline of patients with early-stage Alzheimer’s by 27% relative to placebo in a roughly 2,000-volunteer clinical trial. In the 18-month study, Eisai’s drug also dramatically reduced patients’ levels of beta-amyloid, a toxic protein in the brain thought to drive the advance of Alzheimer’s, and the drug showed statistically significant benefits on three backup measures of cognition and function. (Garde and Wosen, 11/29)

People who got infusions of lecanemab scored about half a point better on a zero-to-18-point scale of mental functioning, a slight but statistically significant difference. The results are "real and robust," says Dr. Christopher van Dyck, who directs the Yale Alzheimer's Disease Research Center and presented an overview of the study at the meeting. (Hamilton, 11/30)

But the detailed results also concluded that the drug, lecanemab, was associated with “adverse events” and warranted more study. Marwan Sabbagh, a neurologist at the Barrow Neurological Institute and a co-author of the study, described two patient deaths that had raised concern about the safety of the drug ahead of Tuesday’s presentation. “Causality with lecanemab is a little difficult,” he said, noting that both patients, a 65-year-old woman and an 87-year-old man, had underlying health issues. Though the rate of brain bleeding was low, he said, the risk increases with medications to prevent blood clotting. (Gilbert, 11/29)

If approved on an accelerated basis, the companies said they would immediately apply for full U.S. regulatory approval which could help secure Medicare coverage. To date, two deaths have been reported among patients who received lecanemab in conjunction with medicine to prevent or clear blood clots, though industry analysts do not expect those developments alone to prevent approval. (Steenhuysen, 11/29)