Alzheimers
Washington (AFP) - The US drug regulator gave full approval to a new Alzheimer's medicine on Thursday, a move that makes it more widely available to the public through government-run health insurance for the elderly. Leqembi, developed jointly by Japan's Eisai and Biogen of the United States, was shown in a clinical trial to modestly reduce cognitive decline among patients in the early stages of the disease. But the study also raised concerns about side effects including brain bleeds and swelling. Leqembi was initially granted "accelerated approval" by the Food and Drug Administration in Janua...
AFP
Washington (AFP) - The US Food and Drug Administration on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer's disease. The FDA approval of the drug, Leqembi, also known as lecanemab, comes just days after the regulatory agency was harshly criticized in a congressional report for its green-lighting of another Alzheimer's drug, Aduhelm. And it was granted despite trial results showing the monoclonal antibody treatment carries risks of brain swelling and bleeding. Both drugs were approved through an accelerated proce...
AFP
September 21 is observed as World .. Day to promote global awareness about Alzheimer and other dementia diseases. Health Analytics Asia convenes its roundtable – Let’s Talk – Coping with Alzheimer’s – an attempt to understand the condition better, and also getting the perspective of a caregiver to dementia patients. By Health Analytics Asia It is a condition that has affected over 7 million people worldwide and has caused over 1.6 million deaths in 2019. In India, the figures are staggering with more than five lakh people affected and more than one lakh deaths in 2019. Alzheimer’s Disease – it...
Health Analytics
Washington (AFP) - The US drug regulator on Thursday said only people with mild dementia should receive the first new Alzheimer's medicine in decades, after facing intense backlash from many in the medical community over its authorization. Biogen's Aduhelm received an "accelerated approval" by the Food and Drug Administration in June, despite the fact that an independent expert panel advising the agency found insufficient evidence of its benefit. "Since the agency approved Aduhelm, prescribers and other stakeholders have expressed confusion regarding the intended population for treatment," FDA...
AFP
When the FDA announced on Monday that it had approved a new Alzheimer’s drug from Biogen, a biotech company based in Massachusetts, economic analysts were not enthusiastic. Though the new drug, Aduhelm, presents some hope to patients and families because it has the potential to slow early-on cognitive decline, there is not yet enough evidence to prove its actual effectiveness, at least not enough to validate its $56,000 annual cost. While its momentum comes from the fact that it is the first drug of its kind for Alzheimer’s in the past two decades, the proposed price is higher than some analys...
uPolitics.com
Washington (AFP) - The United States on Monday approved a drug called Aduhelm to treat patients with Alzheimer's, the first new medicine against the disease in almost two decades and the first to address cognitive decline linked to the condition. The decision was highly anticipated but also contentious, because an independent expert panel convened by the regulatory Food and Drug Administration last November found insufficient evidence of Aduhelm's benefit and recommended against approval. "Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer's disease, the pre...
AFP
Washington (AFP) - The United States on Monday approved a drug called Aduhelm to treat patients with Alzheimer's, the first new medicine against the disease in almost two decades and the first to address cognitive decline linked to the condition. The decision was highly anticipated but also contentious, because an independent expert panel convened by the regulatory Food and Drug Administration last November found insufficient evidence of Aduhelm's benefit. "Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer's disease, the presence of amyloid beta plaques in ...
AFP
Washington (AFP) - A US government expert committee was set to vote Friday on whether to recommend the approval of the first new Alzheimer's drug in almost two decades.The decisions reached by such panels, while nonbinding, are often accepted by the Food and Drug Administration. If it is eventually approved, Biogen's aducanumab would be the first drug ever to treat cognitive decline associated with Alzheimer's -- a major medical milestone.Some in the research community, however, say the evidence in favor of aducanumab is not yet clear-cut and more work needs to be done to prove it really works...
AFP
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