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The FDA adjusts the label of Aduhelm to narrow the use of Biogen drugs to mild Alzheimer’s disease

According to a study, the use of Biogen’s drug Aduhelm should be limited to patients with mild Alzheimer’s disease. change inside Prescription information Announced on Thursday.

initial Approved Aduhelm in June It is widely stated that the drug is “applicable to the treatment of Alzheimer’s disease,” so it is possible to obtain and prescribe the drug for US$56,000 per year. Estimated 5.8 million Americans with neurodegenerative diseases. When updating the label to indicate that the drug should be given to patients with “mild cognitive impairment or mild dementia,” the regulatory agency aligns the indicated use of the drug with the patient population studied in clinical trials.

The updated information further states that “there are no more data on the safety or effectiveness of starting treatment in the early or late stages of the disease than what has been studied.”

Once the drug is approved, doctors may prescribe the way they see fit—regardless of the drug’s label.But after a strong protest against the broad language in the Aduhelm label, Biogen, based in Cambridge, Massachusetts, issued a copy in late June. statement Emphasize that the drug has only been tested in patients in the early stages of Alzheimer’s disease, and that the company’s contacts with medical professionals will focus on this patient population, which the company estimates is between 1 million and 2 million.

Drug label update is Claim Through Biogen. In a prepared statement, Alfred Sandrock, Biogen’s head of research and development, stated that the label change was based on the company’s dialogue with doctors, the FDA, and patient advocates. This is a change as the company and the agency face increasing questions about the efficacy of Aduhelm and the regulatory procedures used to approve it. Even supporters of the drug criticized the product’s annual price tag, most of which will be covered by medical insurance.

Aduhelm is an antibody drug designed to break down amyloid plaques that accumulate on the brain. Although the accumulation of this protein is characteristic of Alzheimer’s disease, it is unclear whether removing amyloid plaques will improve the symptoms of this disease. The main goal of phase 3 clinical trials is to show a reduction in cognitive decline.

After independent analysis found that they were unlikely to achieve the main research goals, Aduhelm’s two Phase 3 tests were stopped in 2019. But Biogen performed another analysis on a larger data set. Based on this new analysis, Biogen stated that one of the two Phase 3 tests was successful. These data are the basis for applications to seek regulatory approval.

An independent panel of medical experts advised the FDA on drug decisions and voted against the proposal to approve Aduhelm. The FDA finally approved the drug based on the agency’s accelerated approval pathway, which is faster than standard review and based on less evidence. Approval under this route can be based on “surrogate endpoints,” which is an indication in clinical trials that the drugs may be effective even if the data does not clearly show that patients benefit. The FDA approved Aduhelm as a surrogate end point for patients with amyloid plaque clearance.

The benefits of Aduhelm must come from additional clinical studies conducted after the drug is marketed. Aduhelm’s confirmatory research may take up to nine years. Congressional hearings may be held sooner. On June 25, the Democratic leaders of the two House committees announced that they would an examination Despite concerns about the benefits of Aduhelm for patients, its approval and pricing.

Photo: wildpixel, Getty Images

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