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CompilationFan Dongdong
As a controversial new drug for Alzheimer’s disease, one month after the approval of Biogen/Biogen’s Aduhelm, the US health regulatory agency updated the new prescription instructions for the drug’s restricted use on Thursday.
A few days ago, the US Food and Drug Administration (FDA) stated that the change in the indication label of Biogen/Eisai’s Alzheimer’s disease drug Aduhelm aims to solve the confusion between doctors and patients about which type of patient should get the drug.
The FDA's updated label emphasizes that Aduhelm is suitable for patients with mild or early Alzheimer's disease, but has not been studied in patients with more advanced stages of the disease
Bojian announced the changes to the drug label in a press release on Thursday, and the company said it reached an agreement on the label revision after communicating with the FDA
When the drug was first approved, a senior FDA official told reporters that the treatment was "associated with all stages of Alzheimer's disease
It is very rare that the drug label of approved drugs undergoes radical changes, especially within a few weeks after the drug is approved
It is worth noting that so far Aduhelm has not been proven to reverse or slow down Alzheimer's disease
After the drug was approved, analysts worried that Aduhelm may add tens of billions of dollars in new expenditures to the U.
The US House of Representatives has launched an investigation into the FDA's review and approval process for the drug
Many hospitals have stated that they plan to limit the use of this drug to patients with early-stage illnesses
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