Jul 8, 2023 09:55 PM
(This post was last modified: Jul 8, 2023 09:58 PM by Magical Realist.)
https://www.nbcnews.com/health/health-ne...-rcna92377
"The Food and Drug Administration on Thursday fully approved the Alzheimer’s drug Leqembi, amid concerns about its safety, cost and accessibility.
The move marks the first time that a drug meant to slow the progression of the disease has been granted full regulatory approval. Other approved drugs only target its symptoms.
"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.
The treatment could "give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love," Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement.
"This gives people more months of recognizing their spouse, children and grandchildren," Pike said..."
"The Food and Drug Administration on Thursday fully approved the Alzheimer’s drug Leqembi, amid concerns about its safety, cost and accessibility.
The move marks the first time that a drug meant to slow the progression of the disease has been granted full regulatory approval. Other approved drugs only target its symptoms.
"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.
The treatment could "give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love," Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement.
"This gives people more months of recognizing their spouse, children and grandchildren," Pike said..."
