The FDA gave full approval to Leqembi, the first drug that can change the course of Alzheimer’s disease, patients a glimmer of hope, and patient advocates and some doctors say it’s the beginning of a new era of Alzheimer’s treatment.
“I don’t think we can understate the significance of this moment,” said Donna Wilcock, the assistant dean of biomedicine at the University of Kentucky.
About 6.7 million adults ages 65 and older in the United States have Alzheimer’s disease, according to the Alzheimer’s Association.
Leqembi, from Japanese drugmaker Eisai and U.S.-based drugmaker Biogen, targets a type of protein in the brain called beta-amyloid, long thought by scientists to be one of the underlying causes of Alzheimer’s disease.
In a phase 3 clinical trial of 1,795 patients with mild cognitive impairment or early-stage disease, progression of the illness was slowed by 27% over an 18-month period.
“While patients still do decline on the drug, the decline is slowed,” Wilcock said.
Dr. Ronald Petersen, a neurologist at the Mayo Clinic in Rochester, Minnesota, said in an email that Leqembi is not a cure, nor does it stop the disease.
“It’s a first step for hopefully more therapeutics in the future,” he said.
The Alzheimer’s Association, which has vocally advocated for the drug’s approval, praised the decision.
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