2023-07-30 05:10:06
Title: Breakthrough Alzheimer’s Drug “Leqembi” Submitted for Approval in EU, Promising Early Detection Method Discovered
Date: July 30, 2023
By: Pamela Dörhöfer
At 5:10 a.m. on July 30, 2023, pharmaceutical companies Biogen and Eisai announced the submission of their application for the approval of lecanemab, the active substance in the Alzheimer’s drug “Leqembi,” to the European Union. This news comes after the recent final approval of “Leqembi” by the US Food and Drug Administration (FDA). The drug, which had already received provisional approval in January, is now permitted for use in patients with early-stage Alzheimer’s disease in the United States.
The positive assessment of “Leqembi” by the medical community has raised hopes of a significant breakthrough in the treatment and diagnosis of Alzheimer’s disease. Howard Fillit, co-founder and scientific director of the US Alzheimer’s Drug Discovery Foundation, described the drug as a “breakthrough” in an article for the medical magazine “Stat.” With over 40 years of experience as a practicing geriatrician, Fillit expressed unparalleled optimism about the potential to revolutionize patient care.
Clinical trials have shown that lecanemab, an antibody targeting the protein amyloid-beta, can effectively reduce the formation of clumps in the brain associated with Alzheimer’s disease. These clumps, known as amyloid-beta deposits, are believed to contribute to cognitive impairment. It is crucial to administer the antibody at an early stage of the disease to slow down its progression.
While “Leqembi” is causing excitement for its potential, another amyloid antibody called aducanumab is also under scrutiny in the United States. The approval of a drug from the same group, Donanemab, manufactured by Eli Lilly, is expected soon. In clinical trials, Donanemab has shown a 35 percent reduction in cognitive decline and requires fewer infusions than “Leqembi.” However, both drugs can have serious side effects due to the rapid removal of clumped proteins by the immune system, leading to brain edema and bleeding.
The key to combating Alzheimer’s lies in early and accurate diagnosis. Currently, positron emission tomography (PET) is the gold standard for detecting amyloid or tau proteins in the brain. However, its complexity, cost, and limited availability hinder its use as routine diagnostics. To address this, C2N Diagnostics developed a blood test that can detect amyloid beta two years ago, which has received approval in both the USA and the EU.
Furthermore, researchers are exploring biomarkers to detect tau protein deposits in the cerebrospinal fluid. An international research team led by neurologist Randall Bateman recently published a study proposing a marker called MTBR-tau243. This marker not only aids in Alzheimer’s diagnosis but also monitors the effects of drug therapy on tau proteins during ongoing treatment.
Alzheimer’s disease is the most common type of dementia, highlighting the urgency to develop reliable and early detection methods. With the submission of lecanemab for approval in the EU and the discovery of potential biomarkers, the medical community is optimistic about the future of Alzheimer’s treatment and diagnosis.]
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