The Food and Drug Administration said the change is intended to address confusion among physicians and patients about who should get the drug, which has faced an intense public backlash since its approval last month.
FILE - This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm. On Thursday, July 8, 2021, U.S. health regulators approved new prescribing instructions for the controversial Alzheimer's drug that are likely to limit use of the expensive therapy, which has faced an intense public backlash. WASHINGTON — U.S. health regulators on Thursday approved new prescribing instructions that are likely to limit use of a controversial new Alzheimer’s drug.
“Hearing these concerns, FDA determined that clarifications could be made to the prescribing information to address this confusion,” the agency said in an emailed statement. Despite the update, the FDA added that “some patients may benefit from ongoing treatment” if they develop more advanced Alzheimer’s.
Because of its price and broad approval some analysts have worried that Aduhelm could add tens of billions in new expenses to the U.S. health care system, particularly the federal government's Medicare program. Alzheimer’s affects about 6 million Americans, the vast majority old enough to qualify for Medicare.
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