US grants full approval to first drug that slows Alzheimer’s disease
The initial medication that decelerates the progress of Alzheimer's disease has been granted complete authorization by the US Food and Drug Administration.
This occurred after extensive testing of the medication, Leqembi, revealed that it reduced the rate of cognitive decline by 27 percent over a span of 18 months.
In this devastating illness, Teresa Buracchio, the person in charge of the Office of Neuroscience at the FDA's Center for Drug Evaluation and Research, declared that the recent development is the initial confirmation that a medication aimed at treating the fundamental causes of Alzheimer's disease has displayed positive outcomes.
This follow-up investigation has validated that it is a secure and reliable therapy for individuals suffering from Alzheimer's disease.
The medication, also referred to as lecanemab, was submitted to the regulatory authorities of Britain in May to seek their approval. Specialists have indicated that it may become accessible in the United Kingdom as early as the following year.
The medication has been hailed as possibly marking "the start of the conclusion" for the illness. It was formulated by Eisai, a pharmaceutical company based in Tokyo, in collaboration with Biogen, an American company.
The medication is given every fortnight through an IV drip and is intended for individuals in the initial phase of their illness with slight cognitive decline.
The FDA has announced its decision to mandate a cautionary statement on product labels alerting consumers to the potential risks of brain swelling and bleeding. During the trials, it was observed that around 21 percent of patients experienced such adverse effects, whereas only nine percent of those who were administered a placebo encountered similar issues.
Additionally, there was a cautionary advisory concerning the administration of the medication to individuals who are already undergoing blood thinning treatment.
The medication is a form of therapy using antibodies, which is administered through injection into the brain. Its mechanism of action involves the decrease of amyloid beta, a protein responsible for the formation of plaques and the subsequent loss of brain cells, a process also associated with brain atrophy.
Patient organizations expressed their approval towards the FDA's ruling.
According to Joanne Pike, the president of the Alzheimer's Association, this therapy, although it may not be a complete solution, has the potential to offer individuals in the initial phases of Alzheimer's disease additional time to uphold their autonomy and partake in activities that bring them joy.
"This allows individuals to have additional months to acknowledge their partner, offspring, and grandchildren."
