A large trial funded by the drug’s makers found Leqembi slowed the progression of Alzheimer’s by 27%.
Leqembi targets a specific protein that forms plaques in the brains of Alzheimer’s patients.
It was approved by the FDA on Thursday. Thursday’s full traditional approval means the drug is now available for coverage by Medicare.
“It’s exciting to have something to offer patients that might slow the progression of the disease,” said Dr. Melissa Yu, AHEAD study lead researcher at Baylor College of Medicine.
The drug does carry some risks: About 13% of patients receiving the drug in its trial had brain swelling and 17% had brain bleeding compared with 9% in the placebo group.
You may remember other drugs such as Aduhelm also aimed to slow progression but was revoked from people outside of clinical trials because of those side effects.
Dr. Yu said Leqembi is different.
“It’s the first drug that Medicare will cover outside of a clinical trial. It’s the first of these types of drugs. So that’s what’s so exciting is the patient does not have to participate in a clinical trial to get the drug. There are steps that the doctor hast to do to get the drug covered from Medicare, but it is different. This is the first drug that has been approved based on the fact that it has clinical affect as well. Based on the fact that we think it actually works and patients,” said Dr. Melissa Yu, AHEAD study lead researcher at Baylor College of Medicine.
Dr. Yu is so confident it works she’s leading a local trial involving the drug AHEAD Alzheimer’s Disease Clinical Trial | The AHEAD Study
This study is trying to determine if Leqembi can prevent Alzheimer’s disease in people without a diagnosis but at high-risk.
“It’s looking at treating people who are at risk of developing Alzheimer’s disease, so what if we gave this medication to people who had a propensity towards developing Alzheimer’s disease in the future? Could we prevent the development or at least delay the development of cognitive symptoms? So that’s really exciting as well, I think this drug will be hopefully available in that regard in the future,” Yu said.
Those who are approved will get an infusion every two weeks.
Experts also warn Leqembi is not a cure.