This traditional approval follows previously fast-tracked authorization.
The Food and Drug Administration (FDA) has approved Leqembi for the treatment of Alzheimer’s disease. The FDA included a safety warning for the drug flagging the risk of potentially dangerous brain swelling.
The drug was initially approved by the FDA in January under the Accelerated Approval pathway. This recent traditional approval was given after confirmation of clinical benefit.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research Acting Director Teresa Buracchio. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
Retired neurosurgeon Dr. Ben Carson said Alzheimer’s is “a very big problem in our society, the sixth leading cause of death, or in some studies, the third leading cause of death in our country.”
As the Lord Leads, Pray with Us…
- For Commissioner Califf as he heads the Food and Drug Administration.
- For FDA officials as they evaluate and review therapies and treatments for various diseases.
- For Acting Director Buracchio as she oversees the Center for Drug Evaluation and Research.
- For those who are experiencing Alzheimer’s disease and the loved ones who care for them.
Sources: Newsmax, Daily Mail, Food and Drug Administration
