FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval
U.S. Food and Drug AdministrationJul 07, 2023
On Thursday, the US Food and Drug Administration (FDA) gave full approval to Biogen and Eisai's Alzheimer's drug Leqembi, the first medication shown in clinical trials to slow the progression of the disease.
The drug — which received accelerated approval from the FDA in January — clears brain plaque associated with Alzheimer's. A confirmatory study of 1.8K patients showed that it slowed cognitive decline by around five months, with the agency calling it "safe and effective."
Leqembi has shown itself to be a safe and effective treatment for Alzheimer's, with the turnaround from accelerated to traditional approval being a testament to the responsiveness of the FDA. Millions of Americans now have hope to slow the progression of this frightening illness, and patients can rest assured that they are getting cutting-edge treatment that has been thoroughly tested and proven to be safe.
The FDA has been proven to be a compromised organization when it comes to the approval of Alzheimer's medication, as they sweep an earlier controversy under the rug. Leqembi co-maker Biogen was found to be inappropriately involved in the FDA approval process for their drug Aduhelm, rushing a medication that was overly expensive with unclear efficacy. There is good reason to be skeptical of this latest drug in light of this history.