FDA trims use of contentious Alzheimer’s drug amid backlash
Associated PressWASHINGTON — A month after approving a controversial new Alzheimer’s drug, U.S. health regulators on Thursday signed off on new prescribing instructions that are likely to limit its use. When the drug was first approved, a top FDA official told reporters the drug was “relevant to all stages of Alzheimer’s disease.” The FDA’s OK last month quickly sparked controversy over Aduhelm’s $56,000-a-year price-tag and questionable benefits. Three of FDA’s outside advisers resigned over the decision with Harvard researcher Dr. Aaron Kesselheim calling it the “worst drug approval decision in recent U.S. history.” On Thursday, Kesselheim tweeted that the change was “a welcome step” but added that the FDA and Biogen should do much more to combat “misperceptions about this drug.” Sweeping changes to drug labels are rare, particularly only a few weeks after approval. “I think this is a positive change because it better reflects the patients in whom the drug was actually studied.” Wall Street analysts said the change wouldn’t significantly impact projected sales for Biogen.