Eventually the Food and Drug Administration gave the official green light to the new anti-Alzheimer’s drug, the first treatment that slows the progression of the disease. The story of this medicine had a troubled storywith several stop and go, until the decisive approval arrived on Thursday 6 July.
Last January This groupThe drug had received accelerated approval from the FDA, but the US drug regulator wanted to re-verify the data.
For whom is the new anti-Alzheimer’s drug useful?
The FDA has approved the drug only for people who:
show i early signs of Alzheimer’s, have moderate cognitive impairment, have moderate dementia with confirmation of having amyloid plaques in the brain. We know that Alzheimer’s disease is characterized by the presence of beta-amyloid protein plaques e neurofibrillary tangles of hyperphosphorylated tau protein. Both of these proteins begin to accumulate in the brain several years before the onset of clinical symptoms.
Alzheimer’s numbers in Italy
It is estimated that about 15% of patients have these characteristics. Alzheimer’s affects about 600,000 people in Italy alone and is the most common form of dementia. Experts argue that in the coming years the figures could also increase significantly. Here because a drug that can slow down the progression of the disease is essential and seen as the beginning of a new era.
Data on new Alzheimer’s drug for people with advanced disease is lacking
Those who experience more advanced forms of the disease do not know if they can have significant benefits from the use of this drug, which justifies a therapy, which also has side effects. More information is needed before making a final decision.
“It is not yet a cure, but a new era begins”
Experts are keen to point out that we are not yet faced with a cure. Leqembi has been shown to slow cognitive decline by 27 percent. A percentage that currently allows patients to be given more time to remain independent and continue their lives autonomously.
The side effects
The drug has side effects and requires monitoring via brain CT scan. Second the results of the experiment circa 13% may have episodes of cerebral bleeding. In some people this situation is even more serious. These are people with certain genetic conditions or who are taking blood-thinning medications.
The drug is taken through an infusion to be done every fifteen days.