2023-07-30 19:01:21
Title: Breakthrough Alzheimer’s Drug “Leqembi” Receives Final Approval in the US
Date: July 30, 2023
Author: Pamela Dörhöfer
Biogen and Eisai, the manufacturers of the Alzheimer’s drug “Leqembi,” have submitted an application for approval in the European Union. This follows the recent final approval granted by the US Food and Drug Administration (FDA) for the drug’s use in early-stage Alzheimer’s patients. The approval of “Leqembi” has garnered optimism among experts, including Howard Fillit, co-founder and scientific director of the US Alzheimer’s Drug Discovery Foundation.
“Leqembi” contains lecanemab, an antibody that targets the protein amyloid-beta, which forms clumps in the brain of Alzheimer’s patients. The drug’s approval marks a significant breakthrough in Alzheimer’s treatment, as most drugs in development target amyloid beta. According to Fillit, this new drug has the potential to change the way patients are diagnosed and treated.
However, it is crucial to administer this antibody at an early stage when cognitive impairments are minimal. The treatment requires intravenous administration every two weeks. Another amyloid antibody, aducanumab, is also on the market, but its effectiveness is still controversial. Donanemab, a drug in clinical trials by Eli Lilly, is reported to have slowed cognitive decline by 35 percent and requires infusions every four weeks.
Both “Leqembi” and Donanemab can have serious side effects due to the rapid removal of clumped proteins, which can lead to edema and bleeding in the brain. It is therefore imperative to diagnose Alzheimer’s before symptoms manifest, as these drugs can no longer slow down the progression of the disease at later stages.
Detecting Alzheimer’s at an early stage is crucial, and current methods such as positron emission tomography (PET) scans are complex and expensive. A blood test developed by C2N Diagnostics, approved in both the US and the EU, detects amyloid beta in the blood and offers a relatively new diagnostic option. Additionally, researchers led by neurologist Randall Bateman published data on a potential biomarker called MTBR-tau243, which detects tau protein deposits in the cerebrospinal fluid. This biomarker could aid in diagnosing Alzheimer’s and monitoring the effects of drug therapy on tau proteins during treatment.
Alzheimer’s remains the most common type of dementia, but it is essential to continue researching methods for early and reliable diagnosis. With the approval of “Leqembi” and ongoing research into diagnostic biomarkers, there is newfound hope for improving the lives of those affected by this devastating disease.
Disclaimer: The content of this article is for informational purposes only and does not constitute medical advice.]
#Alzheimers #antibody #receives #final #approval