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New Alzheimer's drug gets full FDA approval at $26,000. per annum, heed the warnings
[The Hill] It marks the first-ever approval of a drug proven to moderately slow the course of Alzheimer’s disease.The FDA said the approval was based on clinical trial data that showed Leqembi, from drugmakers Eisai and Biogen, slows cognitive decline by about 27 percent compared to a placebo among Alzheimer’s patients who are in the early stages of the disease. But the agency also added a black box warning to the label, a nod to the concerns over serious side effects. The FDA said that in rare cases the drug can cause "serious and life-threatening events" and that there have been cases of brain bleeding, "some of which have been fatal." "Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease," said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. Posted by: Besoeker 2023-07-07 |
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