Health
The FDA has updated the label on the controversial drug for Alzheimer’s disease, stating that it is only for early-stage patients.
1 month after controversial approval New Alzheimer’s disease drug, US health regulators approved new prescribing instructions on Thursday that may limit its use.
The Food and Drug Administration said the change aims to address the confusion between doctors and patients about who should take the drug, which has faced a fierce backlash since its approval last month.
The label of the new drug is that the drug AduhelmIs suitable for patients with mild or early-stage Alzheimer’s disease, but has not been studied in patients with more advanced disease. This is a major change from the original FDA’s instructions, which simply stated that the drug was generally approved for Alzheimer’s disease.
Drug maker Biogen announced the change in a Thursday release, saying the update aims to “clarify” the patients studied in the company’s trials that led to the approval. The FDA first approached the company on narrowing the label and accepted the language.
“Hearing these concerns, we have determined that the FDA can clarify prescribing information to address this confusion,” the FDA said in an email statement. Despite the update, the FDA added that “some patients may benefit from continued treatment” if they develop more advanced Alzheimer’s disease.
When the drug was first approved, FDA executives told reporters that the drug was “related to all stages of Alzheimer’s disease.”
Last month’s FDA action sparked controversy over the $ 56,000 annual price tag and suspicious profits. Three of the FDA’s external advisors have resigned from the decision, and one prominent Harvard expert has called it “the worst drug approval decision in US history these days.”
Such drastic changes in drug labels are rare, especially only a few weeks after approval.
Dr. Ronald Petersen of the Mayo Clinic, who consulted with Biogen and other pharmaceutical companies, said: Side effects of the drug include swelling and bleeding of the brain.
Aduhelm has not been shown to reverse or significantly delay the disease. However, the FDA said its ability to reduce plaque mass in the brain is likely to delay dementia. Many experts say that there is little evidence to support that claim.
Biogen needs to carry out follow-up to clearly answer whether the drug delays mental decline. Other Alzheimer’s disease medications only temporarily relieve symptoms.
Due to its price and widespread approval, some analysts are concerned that Aduhelm could add tens of billions of new costs to the US healthcare system, especially the federal Medicare program. Alzheimer’s disease affects about 6 million Americans, the majority of whom are old enough to qualify for Medicare.
Two parliamentary committees in the House of Representatives have begun investigating drug reviews by the FDA. Senators then called for a hearing on drug costs and their impact on federal spending.
Narrower labels may alleviate some of those concerns by reducing the number of patients who may take medications that require monthly IV. Many hospitals have already stated that they plan to limit drug use to patients with early-stage illness. Citing the FDA label, insurers may refuse to pay, but doctors can still prescribe medications for more advanced patients.
“It was quite annoying that the previous label was very extensive and included a group of patients who had never been tested,” said Dr. Susanne Sindler of Washington University in St. Louis. “I think this is a positive change as the drug better reflects the patients actually studied.”
Wall Street analysts said the change wouldn’t have a significant impact on Biogen’s projected sales. Jeffreys’ Michael Yi said in a research note that the company already plans to focus its outreach on 1 to 2 million Americans with mild Alzheimer’s disease.
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