One month after approving its use, the United States limited the scope of a new drug against Alzheimer’s disease

One month after the approval of a new Yes controversial drug to treat Alzheimer’s disease, US regulators released on Thursday new prescribing instructions that will likely limit its use.

The Food and Drug Administration (FDA) said the goal of the change is to meet the confusion between doctors and patients about who should use the remedy, whose approval last month sparked a intense backlash.

The new label emphasizes that the drug Adulhelm is appropriate for patients with mild or early-stage Alzheimer’s disease, but that it has not been studied in patients with more advanced stages of the disease. The original instructions from the FDA stated that the drug had been approved for the treatment of Alzheimer’s disease in general.

The manufacturer Biogen announced the change on Thursday, indicating that the goal of the update is to “Clarify” who were the patients studied during tests carried out by the laboratory and resulting in an approval. The FDA invited the company to clarify the label and approved the text.

“After learning about these concerns, the FDA determined that the prescribing information could be clarified in order to clear up this confusion.The agency said in an emailed statement. Despite the update, the FDA added that “some patients may benefit from continued treatment“If his Alzheimer’s disease progresses.

When the drug was first approved, a senior FDA official told reporters it was “suitable for all stages of Alzheimer’s disease.”

The FDA’s decision last month immediately generated a controversy over the price of the drug, $ 56,000 for a year of treatment and its questionable benefits. Three external FDA advisers quit after ruling and well-known Harvard University expert called him “Worst drug decision in recent US history.”

Large-scale changes in drug labels are unusual, especially if there is just a few weeks after approval.

“It is a responsible decision for the FDA and Biogen to maximize safety while giving the drug the best chance to work,” said Dr Ronald Petersen of the Mayo Clinic, who has served as an advisor to Biogen and other companies. pharmaceuticals. Side effects of the drug include swelling of the brain and bleeding.

(By Matthew Perrone – AP)

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