The Food and Drug Administration granted accelerated approval for Eisai and Biogen's experimental Alzheimer's drug, lecanemab, on Friday, offering a new treatment option for the more than 6.5 million people with Alzheimer's in the United States.
Lecanemab, which targets a type of plaque in the brain made up of the protein beta-amyloid that is believed to cause memory and cognitive problems, showed promising results in slowing the rate of cognitive decline among patients in the early stages of Alzheimer's in a Phase 3 trial, potentially setting it up to garner millions in revenue once it hits the market.
The drug has been one of first to have success in slowing the progression of the disease that has no known cure, but reports of serious adverse events with trial patients, including brain swelling and bleeding, had raised some questions about its safety. The FDA said lecanemab, which will be sold under the name Leqembi, should be started in patients with"mild cognitive impairment or mild dementia stage of disease." The most common side effects are infusion-related reactions, headache, and amyloid-related imaging abnormalities or ARIA, which usually does not have symptoms but could lead to some rare serious and life-threatening events.
Indonesia Berita Terbaru, Indonesia Berita utama
Similar News:Anda juga dapat membaca berita serupa dengan ini yang kami kumpulkan dari sumber berita lain.
FDA grants accelerated approval to Alzheimer's drug for people with early stage diseaseBREAKING: FDA grants accelerated approval to new Alzheimer's treatment that can slow cognitive decline in people with early stages of the disease.
Baca lebih lajut »
FDA grants fast-track approval to experimental Alzheimer's drugThe FDA approved lecanemab, which has shown to slow the progression of Alzheimer's disease.
Baca lebih lajut »
New Alzheimer’s Drug Approved by FDA, Promises to Slow DiseaseBreaking: A new Alzheimer's drug has been cleared for use in the U.S. Doctors say it could transform the way the disease is treated.
Baca lebih lajut »
Alzheimer’s drug that slows cognitive decline gets FDA approvalThe drug, lecanemab, removes a sticky protein from the brain called amyloid beta, which is thought to play a key role in the memory-robbing illness.
Baca lebih lajut »
FDA approves new Alzheimer’s drug that appears to slow progression of diseaseBREAKING: FDA approves Alzheimer’s drug shown in clinical trials to slow cognitive decline in patients in the early stages of the illness.
Baca lebih lajut »
FDA Approves Alzheimer's Drug That Modestly Slows DiseaseThe drug, Leqembi, is the first that’s been convincingly shown to slow the decline in memory and thinking that defines Alzheimer’s.
Baca lebih lajut »