In A Reversal, FDA Calls for Limits on Who Takes Alzheimer’s Drugs


Faced with harsh criticism for approving a controversial drug for all Alzheimer’s patients, the Food and Drug Administration has largely narrowed his recommendationsuggests that only those with mild memory or thinking problems should take it.

The FDA’s turn, quite unusual for a drug that has only been on the market for a few weeks, could significantly reduce the number of eligible patients. The initial label, which said the drug might be suitable for anyone with Alzheimer’s, covered nearly six million Americans. Under the revised label, as many as two million Americans would still be eligible.

Medicare and private insurance companies can use the new label to restrict coverage of the drug, called Aduhelm. This may alleviate the financial burden of the drug, especially on Medicare, which is expected to bear the bulk of monthly intravenous infusion therapy. The drug’s maker, Biogen, charges $56,000 a year for the drug, and diagnostic and safety monitoring costs can add tens of thousands of dollars to the bill.

“Since the agency has approved Aduhelm, prescribers and other stakeholders have expressed confusion regarding the intended population for the treatment,” said FDA spokesperson Michael Felberbaum. Stages of deterioration or mild dementia of Alzheimer’s disease,” he said. This is the population included in clinical trials.

approval aduhelm It has been one of the most controversial FDA decisions in recent years, largely because many scientists and the FDA’s own independent advisory committee, say that the evidence does not convincingly show that the drug works. And in addition to the endorsement itself, the agency’s surprisingly broad label is a concert stormn among many Alzheimer’s experts, even those who support approval of the drug.

The FDA initiated the labeling change, and Biogen agreed to submit the revised language. Biogen has said in recent weeks that it aims to market the drug’s use to patients similar to those in a clinical trial.

In a late-stage clinical trial, the highest dose of the drug was seen to slow patients’ cognitive decline by a fraction of an 18-point point. scale Rate memory, problem-solving skills, and function. But in a second similarly designed clinical trial, the drug showed no benefit.

The agency approved the drug under a route known as accelerated approval, more commonly used for cancer drugs, based on its ability to reduce levels of amyloid, a protein that builds up in plaques in the brains of Alzheimer’s patients and is considered a biomarker. disease. But many Alzheimer’s experts say there’s not yet convincing evidence that lowering amyloid levels can have any effect on people’s memory and thinking problems.


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