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FDA calls for investigation into approval of Biogen’s new Alzheimer’s drug

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In the face of questions about the approval process, the acting commissioner of the Food and Drug Administration is asking for an independent review of what led to last month’s approval of a controversial Alzheimer’s drug from Massachusetts-based Biogen. Aduhelm, made by Cambridge-based Biogen, was the first new drug approved for Alzheimer’s disease in nearly 20 years. Also known as aducanumab (pronounced “add-yoo-CAN-yoo-mab”), it won FDA approval in June despite warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. Officials said the decision was based on results indicating the medication is “reasonably likely” to benefit Alzheimer’s patients.Additionally, questions have been raised about the interactions between Biogen representatives and FDA personnel during the review process for the drug. Acting FDA Commissioner Dr. Janet Woodcock on Friday asked the agency’s Acting Inspector General to conduct an independent review of those interactions. “To the extent, these concerns could undermine the public’s confidence in FDA’s decision, I believe it is critical that the events at issue be reviewed by an independent body,” Woodcock wrote in a letter. Given the high-profile situation, Woodcock asked that the investigation begin “as soon as possible.”

In the face of questions about the approval process, the acting commissioner of the Food and Drug Administration is asking for an independent review of what led to last month’s approval of a controversial Alzheimer’s drug from Massachusetts-based Biogen.

Aduhelm, made by Cambridge-based Biogen, was the first new drug approved for Alzheimer’s disease in nearly 20 years.

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Also known as aducanumab (pronounced “add-yoo-CAN-yoo-mab”), it won FDA approval in June despite warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. Officials said the decision was based on results indicating the medication is “reasonably likely” to benefit Alzheimer’s patients.

Additionally, questions have been raised about the interactions between Biogen representatives and FDA personnel during the review process for the drug.

Acting FDA Commissioner Dr. Janet Woodcock on Friday asked the agency’s Acting Inspector General to conduct an independent review of those interactions.

“To the extent, these concerns could undermine the public’s confidence in FDA’s decision, I believe it is critical that the events at issue be reviewed by an independent body,” Woodcock wrote in a letter.

Given the high-profile situation, Woodcock asked that the investigation begin “as soon as possible.”

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