ALBAWABA - The U.S. Food and Drug Administration (FDA) has approved new Alzheimer's treatment from Eli Lilly for adults with early symptomatic Alzheimer's disease, brand named Kisunla, following multiple delays and regulatory hurdles.
According to a statement by Eli Lilly, Kisunla “demonstrated very meaningful results for people with early symptomatic Alzheimer's disease” including individuals with verified amyloid pathology who have moderate cognitive impairment (MCI) or the mild dementia stage of AD.
According to the Alzheimer's Association, Alzheimer's disease affects around 7 million people in the United States and ranks as the fifth largest cause of mortality for those over the age of 65. It is anticipated that by the year 2050, the number of those suffering would have increased to about 13 million in the United States.
In March, the Food and medicine Administration (FDA) unexpectedly postponed its approval of the drug, which it had previously denied owing to a lack of adequate evidence, according to CNBC. The medication later received appraisal for complete clearance by an advisory group to the FDA last month, which said that the advantages of the treatment exceed the risks.
According to Lilly, the medication "Donanemab" will be marketed under the brand name Kisunla and will cost $695 each vial before insurance. Based on when the patient finishes their therapy, this could add up to $12,522 for a six-month course of treatment or over $32,000 for a year. Although clinical trials notes that the drug is not a cure, they did reveal that it delayed the course of Alzheimer's disease.
Howard Fillit, M.D., Co-Founder and Chief Science Officer at the Alzheimer's Drug Discovery Foundation (ADDF), said that “this approval marks another step forward in evolving the standard of care for people living with Alzheimer's disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer's community.”
