The FDA has greatly limited who it says should be given the Alzheimer's drug Aduhelm, which it approved last month for all patients despite the drug being designed for those dealing with mild symptoms.gettyA new label on the drug's packaging now recommends it only be given to early stage Alzheimer's patients.
On June 7, the FDA approved the drug for all patients, despite concerns over its effectiveness and cost. The drug comes with a price tag of $56,000 a year, which does not include costs for additional testing and scans patients would need. The expensive cost of Aduhelm combined with the fact around 6 million Americans suffering from Alzheimer’s disease would have been eligible—and unlikely to benefit from the drug—sparked concerns it would have caused an undue financial burden for Medicare.
Around 2 million Americans will still be eligible will be eligible under the revised drug labeling, according to“Biogen submitted a label update based on dialogue with FDA, physicians and patient advocates to further clarify the patient population,” Biogen spokeswoman Cindy Manieri said in a statement.An independent FDA advisory panel told the agency it should not approve the drug, but the FDA did so anyway.
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