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FDA Changes Prescribing Instructions for Controversial Alzheimer’s Drug

July 8, 2021 by Dan McCue

U.S. health regulators on Thursday approved new prescribing instructions that are likely to limit use of a controversial new Alzheimer’s drug.

The announcement came through Biogen Inc., the maker of Aduhelm, which stated the update is intended to “clarify” the patients studied in the company trials that led to approval.

The new labeling approved by the FDA state’s the drug is appropriate for patients exhibiting signs of mild cognitive impairment or mild dementia.

When the drug was first approved a top FDA official told reporters the drug was “relevant to all stages of Alzheimer’s disease.”

But that led to weeks of blowback and consternation. The FDA then approached the company about narrowing the label and approved the language to address confusion among physicians and patients.

The FDA now warns that there is “no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.” 

Biogen’s head of research and development, Dr. Alfred Sandrock, Jr. said the new labeling is based “on our ongoing conversations with prescribing physicians, FDA and patient advocates. 

“We submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval,” he added.

Despite the update, the FDA added that “some patients may benefit from ongoing treatment” if they develop more advanced Alzheimer’s.

The label change comes one month after FDA’s approval of the drug, which quickly sparked controversy over its $56,000-a-year price-tag and questionable benefits. 

Three of FDA’s outside advisers resigned over the decision with one prominent Harvard expert calling it the “worst drug approval decision in recent U.S. history.”

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