
Narrower Label for Alzheimer Disease Treatment, Aducanumab
Following criticism for its wide-labeled June approval, the FDA has decided to narrow the patient recommendation for aducanumab.
Weeks of criticism for the approval of Biogen’s aducanumab for the treatment of anyone with Alzheimer disease (AD) has led to the US Food and Drug Administration (FDA) deciding to
The FDA stated that there is “no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”1
Aducanumab—Biogen’s anti-amyloid, disease-modifying agent—is the
After “ongoing conversations with prescribing physicians, FDA and patient advocates,” Biogen requested the update. Research head
Following the original FDA approval, criticism and questions arose concerning the
Furthermore, this new label could help narrow reimbursement decisions and get aducanumab to the appropriate patients faster, according to Jefferies analysts.
“It helps get people going on the right direction to refined and appropriately focused reimbursement, which helps get everyone comfortable that
Biogen reported satisfaction with this update.
References
1. Higgins-Dunn N. Biogen, FDA walk back controversial Aduhelm label after weeks of fierce criticism. Fierce Pharma. July 8, 2021. Accessed July 8, 2021.
2. US Food and Drug Administration. FDA grants accelerated approval for Alzheimer’s drug. June 7, 2021. Accessed July 8, 2021.
3. Kuntz L. First new treatment approved for Alzheimer disease in nearly 2 decades. June 7, 2021. Accessed July 8, 2021.
4. Biogen. FDA approves updated ADUHELM™ prescribing information to emphasize population studied in clinical trials. News release. July 8, 2021. Accessed July 8, 2021.
5. Higgins-Dunn N. A $57B drug? Medicare faces a massive bill for Biogen's Aduhelm—even if it limits coverage. Fierce Pharma. June 24, 2021. Accessed July 8, 2021.
6. Reuters staff. U.S. FDA narrows use of Biogen Alzheimer's drug; shares rise. News release. July 8, 2021. Accessed July 8, 2021.
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