U.S. health advisers are backing the full approval of an Alzheimer's drug that received preliminary approval last year.
drug, a key step toward opening insurance coverage to U.S. seniors with early stages of the brain-robbing disease.
The FDA’s initial OK for Leqembi came via the agency’s accelerated approval program, which allows early access to drugs based on laboratory or biological measures suggesting that they might help patients. The drug, marketed by Eisai and Biogen, helped clear a brain plaque that is a hallmark of Alzheimer’s.
Normally the process of converting an accelerated approval attracts little attention, and FDA rarely convenes its advisers to weigh in on such decisions. Leqembi is priced similarly at $26,500 per year and the handful of patients who have received it to date have mainly had to pay out of pocket.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Alzheimer’s advocates rally for Medicare coverage of newly approved FDA treatmentsNew treatments for Alzheimer’s are on the market, but the price tag is making them inaccessible. The new treatments are not covered by Medicare or Medicaid, which is something the Alzheimer’s Association is trying to change.
Read more »
Eisai-Biogen Alzheimer's Drug Data Confirms Benefits: FDAUS Food and Drug Administration staff on Wednesday said data from a late-stage trial of Eisai and Biogen's Alzheimer's disease drug suggests it offered a meaningful benefit to patients.
Read more »
FDA panel weighs US approval for Alzheimer's drug from Eisai and BiogenA panel of expert advisers on Friday began their meeting to discuss whether to recommend traditional U.S. regulatory approval for Eisai and Biogen's new Alzheimer's drug Leqembi, a move expected to expand Medicare payment for the treatment.
Read more »
FDA advisers vote that lecanemab shows benefit as an Alzheimer’s treatment | CNNAn advisory panel for the US Food and Drug Administration voted unanimously Friday that the Alzheimer’s drug lecanemab shows “clinical benefit” for the treatment of the disease, paving the way for the medication to be considered for full FDA approval, which is expected by July 6.
Read more »
FDA Finalizes Limit on How Much Arsenic Can Be in Apple JuiceFederal regulators have finalized new guidance on how much inorganic arsenic can be present in apple juice, in an effort to limit the exposure of infants and young children to this environmental contaminant.
Read more »
Tactile stimulation at 40 Hz may help in Alzheimer's treatmentNew MIT study says whole-body stimulation improved motor performance, reduced phosphorylated tau, preserved neurons and synapses, and reduced DNA damage.
Read more »