Aduhelm, the new Alzheimer's drug that costs $56,000 a year, is getting its label revised a month after its approval.
The move by U.S. health regulators for updated prescribing instructions was approved Thursday after the Food and Drug Administration's (FDA) original label said the drug can be used for all stages of Alzheimer's, the Associated Press reported. The revised label will say the drug is for those with early or mild Alzheimer's and will note the drug has not been studied for its effects on people with more advanced stages.
"It was pretty troubling that the previous label was so broad and included groups of patients in whom the drug had never been tested," Dr. Suzanne Schindler of Washington University in St. Louis told the AP. "I think this is a positive change because it better reflects the patients in whom the drug was actually studied."
The drug's pricing is a point of controversy, including for Senate lawmakers, and three outside advisers for the FDA resigned over the drug's approval, the AP said.
For more reporting from the Associated Press, see below:
The FDA said the label 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.
Drugmaker Biogen announced the change in a release Thursday, stating that the update is intended to "clarify" the patients studied in the company trials that led to approval. The FDA first approached the company about narrowing the label and approved the language.
"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.
When the drug was first approved a top FDA official told reporters the drug was "relevant to all stages of Alzheimer's disease."
Controversy ignited over its $56,000-a-year price tag and questionable benefits. One prominent Harvard expert called the drug's approval the "worst drug approval decision in recent U.S. history."
Such sweeping changes to drug labels are rare, particularly only a few weeks after approval.
Aduhelm hasn't been shown to reverse or significantly slow the disease. But the FDA said that its ability to reduce clumps of plaque in the brain is likely to slow dementia. Many experts say there is little evidence to support that claim.
Biogen is required to conduct a follow-up study to definitively answer whether the drug slows mental decline. Other Alzheimer's drugs only temporarily ease symptoms.
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.
Two congressional committees in the House have launched an investigation into the FDA's review of the drug. And lawmakers in the Senate have called for hearings into the drug's cost and impact on federal spending.
The narrower label may ease some of those concerns by shrinking the number of patients likely to get the drug, which requires monthly IVs. Many hospitals have already stated that they plan to limit the drug's use to patients with earlier-stage disease. Doctors could still prescribe the drug for more advanced patients, though insurers might refuse to pay for it, citing the FDA label.
