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 narrow the aducanumab recommendation to only patients with milder forms of AD.1
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 first new treatment approved for Alzheimer disease since 2003.2 It was approximately a month ago, June 2021, when the drug received wide-label approval from the FDA.3
After “ongoing conversations with prescribing physicians, FDA and patient advocates,” Biogen requested the update. Research head Alfred Sandrock Jr, MD, PhD, told the press this: “[W]e submitted this label update with the goal to further clarify the patient population that was studied across the 3 [aducanumab] clinical trials that supported approval. We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option.”4
Following the original FDA approval, criticism and questions arose concerning the potential payer budget problemaducanumab would cause.5 Medicare, which covers most AD patients in the US, might not be able to cover the cost of aducanumab. However, Biogen maintains that aducanumab’s launch would only target the 1 to 2 million mild disease patients, rather than the entire AD market.
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 the right people will get the drug,” Jefferies analyst Michael Yee said to the press.6
Biogen reported satisfaction with this update.
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. https://www.fiercepharma.com/pharma/facing-pushback-biogen-and-fda-agree-to-narrow-aduhelm-s-broad-label?mkt_tok=Mjk0LU1RRi0wNTYAAAF-JWkHTIeL0uFqfSeMOe7ihwmdeyy8jOopH3QueVDjp1-zlnj6tmhh5ijO--P6DNp1Uwf1fnemcemk5285MEDwewcfLhm9kqk9JrshzwCUCjKlKo0pHL4&mrkid=112621670
2. US Food and Drug Administration. FDA grants accelerated approval for Alzheimer’s drug. June 7, 2021. Accessed July 8, 2021. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug
3. Kuntz L. First new treatment approved for Alzheimer disease in nearly 2 decades. June 7, 2021. Accessed July 8, 2021. https://www.psychiatrictimes.com/view/first-new-treatment-approved-for-alzheimer-disease-in-nearly-2-decades
4. Biogen. FDA approves updated ADUHELM™ prescribing information to emphasize population studied in clinical trials. News release. July 8, 2021. Accessed July 8, 2021. https://investors.biogen.com/news-releases/news-release-details/fda-approves-updated-aduhelmtm-prescribing-information-emphasize
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. https://www.fiercepharma.com/pharma/11-500-copays-and-diagnostic-hoops-biogen-s-alzheimer-s-56k-drug-aduhelm-set-to-balloon
6. Reuters staff. U.S. FDA narrows use of Biogen Alzheimer's drug; shares rise. News release. July 8, 2021. Accessed July 8, 2021. https://www.reuters.com/article/us-biogen-alzheimers-fda/us-fda-narrows-use-of-biogen-alzheimers-drug-shares-rise-idUSKCN2EE18V