Leqembi launched: First of kind anti Alzheimer's drug gets FDA go-ahead
"I don't think we can understate significance of this moment," says a biomedicine expert while commenting on Leqembi approval
July 07, 2023
After the third phase of clinical trials of hundreds of patients showed promising results in slowing the disease progression, the US Food and Drug Administration (FDA) granted full approval to the Alzheimer’s drug Leqembi Thursday, reported NBC News.
It has been the first time that a drug responsible for slowing down dementia-causing disease has been granted approval.
"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.
According to Alzheimer’s Association which praised the decision, about 6.7 million adults ages 65 and older in the US have Alzheimer’s.
In the trials involving patients with mild cognitive impairment or early-stage disease, the 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, told NBC News 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 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 recognising their spouse, children and grandchildren," Pike said.
The trial of patients was conducted by measuring their performance in six categories: memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care.
Dr Alberto Espay, a neurologist at the University of Cincinnati College of Medicine, said that the 27% slowing in the progression of the illness falls below the threshold of what would be "noticeable" to a patient.
"The odds for brain swelling and haemorrhage are far higher than any actual improvement," said Espay, who launched a petition in June calling for the Alzheimer’s treatment to not get full approval.
In its approval, the FDA included its strongest warning label — called a boxed warning — about these particular side effects, noting that they can lead to seizures and death.
In addition, before starting the drug, patients should undergo genetic testing to better understand their risk for these side effects.
Petersen said that in about 75% of people, the brain side effects, which were detected on MRI scans, did not cause symptoms.
Leqembi would be used for people with mild cognitive impairment or early-stage Alzheimer's disease and will be only infused in hospitals or clinics.
