Manufactured by Eisai and Biogen, Leqembi promises to slow the cognitive decline of patients
The FDA is focusing on a new medication created by Eisai and Biogen that slows down cognitive decline in Alzheimer's patients who have not yet progressed to the advanced stage of the illness.
The FDA has promised the "expedite green light" since it is a very debilitating disease for those who are ill and an equally demanding pathology for those who care for it. However, it has asked the two pharmaceutical firms to carry out more research. According to Billy Dunn from the Food and Drug Administration: “What's new,” he says, “this treatment option targets the underlying process rather than just treating the symptoms."
Leqembi, the new drug, targets the disease's fundamental pathophysiology from a completely new perspective and is meant to "act on the pathological process" rather than only reduce the symptoms. The drug has shown promising results for the treatment of the disease, which affects 6.5 million people worldwide.
Leqembi has been shown to significantly delay the disease progression, which has been the focus of years of research. To prevent or slow down cognitive decline for some months, it is crucial to start taking this new medication as soon as symptoms appear. However, given how aggressive, disabling, and common the disease is, this is already a significant improvement in the quality of life for both patients and their families.
According to Joy Snider, a neurologist at Washington University in St. Louis, this translates into the patient being able to "drive" a car for around 6 months longer, which is vital for the patient’s autonomy and dignity. In any case, the FDA makes it clear that additional studies and research are required, even if the initial results obtained in the experimental phase show the effectiveness of the drug. The manufacturing companies said that they have already submitted a dossier to EMA for approval in Europe. We'll have to wait till then as well, in Italy for the evaluation of AIFA.
A portion of the scientific community, particularly Dr. Mattew Schrag, a researcher at Vanderbilt University, who believes the efficacy is below the threshold of what the scientific community considers clinically relevant, has doubts about Leqembi. However, the disease does appear to progress more slowly, and "in the economy of the course" the five or six months during which the progression slows down unquestionably improves the quality of life, particularly for the patient, who gains clarity prior to cognitive decline. In the future, the hope is that these investigations will point us in the direction of a permanent solution. In any case, the "change of perspective" brought by this drug, which acts on the root causes and triggering factors rather than the symptoms, paves the way for future approaches.
Prof Antonio Giordano first published this article in Italian for La Voce Di New York, click here to read.
Professor Antonio Giordano, M.D., Ph.D. is the Founder and Director of Sbarro Health Research Organization based at the College of Science and Technology, Temple University, Philadelphia. Connect with him on his social media channels to follow more updates: (Facebook, LinkedIn, Twitter, Instagram)