[ad_1]
A month after approving a controversy new drug for Alzheimer’s disease, U.S. health regulators on Thursday approved new prescribing instructions that may limit its use.
The Food and Drug Administration said the change was intended to clear up confusion among doctors and patients over who should get the drug, which has faced intense public backlash since its approval last month.
The new drug label emphasizes that the drug, Aduhelm, is 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 big change from the original FDA instructions, which simply said the drug was approved for Alzheimer’s disease in general.
Drugmaker Biogen announced the change in a statement on Thursday, saying the update is intended to “clarify” the patients being studied in the company’s trials that led to the approval. The FDA first approached the company to restrict the label and approved the language.
“Upon hearing these concerns, the FDA determined that clarification 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 disease.
When the drug was first approved, a senior FDA official told reporters the drug was “relevant to all stages of Alzheimer’s disease.”
The FDA’s action last month quickly sparked controversy over its $ 56,000-per-year price tag and questionable benefits. Three of the FDA’s external advisers resigned over the move, with a leading Harvard expert calling it “the worst drug approval decision in recent US history.”
Such drastic changes to drug labels are rare, especially just weeks after approval.
“It is a responsible decision on the part of 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 been a consultant for Biogen and other drug manufacturers. Side effects of the drug include swelling of the brain and bleeding.
Aduhelm has not been shown to reverse or significantly slow down the disease. But the FDA said its ability to reduce plaque buildup in the brain is likely to slow dementia. Many experts say there is little evidence to support this claim.
Biogen is to conduct a follow-up study to determine for sure whether the drug is slowing mental decline. Other drugs for Alzheimer’s disease only temporarily improve symptoms.
Because of its price tag and wide approval, some analysts fear Aduhelm will add tens of billions in new spending to the U.S. healthcare system, especially the federal government’s Medicare program. Alzheimer’s disease affects an estimated 6 million Americans, the vast majority old enough to qualify for Medicare.
Two Congressional House committees have launched an investigation into the drug’s review by the FDA. And Senate lawmakers have called for hearings on the cost of the drug and its impact on federal spending.
The narrower label may alleviate some of these concerns by reducing the number of patients who are likely to get the drug, which requires monthly IVs. Many hospitals have already said they plan to limit the use of the drug to patients with early-stage illness. Doctors could still prescribe the drug to more advanced patients, although insurers could refuse to pay for it, citing the FDA label.
“It was quite disturbing that the previous label was so broad and included groups of patients in whom the drug had never been tested,” said Dr. Suzanne Schindler of Washington University in St. Louis. “I think this is a positive change because it better reflects the patients in whom the drug has actually been studied.”
Wall Street analysts said the change would not have a significant impact on Biogen’s projected sales. Michael Yee of Jefferies said in a research note that the company already plans to focus on the 1 to 2 million Americans with mild Alzheimer’s disease.
.
|
Sources 2/ https://www.cbsnews.com/news/fda-new-guidance-alzheimers-drug-biogen-aduhelm/ The mention sources can contact us to remove/changing this article |
[ad_2]