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# Cavazzoni Tries to Repair Credibility with New Alzheimer’s OK
- URL: https://www.fdaweb.com/cavazzoni-tries-to-repair-credibility-with-new-alzheimers-ok/
- Published: 2023-01-06T12:00:00.000Z
- Updated: 2026-09-14T18:11:06.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153488

CDER director **Patrizia Cavazzoni** is attempting to restore credibility within her Center by announcing the accelerated approval for a Biogen/Eisai BLA for Leqembi (lecanemab-irmb) for treating Alzheimer’s disease (AD), while also addressing previous controversies with the 2021 approval of Biogen’s Aduhelm (aducanumab). Leqembi is the second expedited approval of a monoclonal antibody drug for treating Alzheimer’s disease; the first being [Aduhelm](https://www.fdaweb.com/uproar-greets-fdas-aduhelm-ok-for-alzheimers/). Both drugs target amyloid plaque, a core pathogenic feature of AD, whereas symptomatic treatments were only previously available, according to FDA.

“While the approval of Aduhelm generated a significant amount of discussion among external stakeholders, CDER’s work during the review of the aducanumab application led to a leap in our understanding of amyloid as a surrogate marker and a greater understanding of the role that a reduction in amyloid plaque may play in a slowing of the disease,” she wrote in a [separate memo](http://www.fdaweb.com/download.php?file=cavazzoni%5F1-23.docx) to staff about the approval action.

Turning to the recent critical [Congressional report](https://www.fdaweb.com/reactions-to-aduhelm-report-blast-fda-closeness-to-industry/) about CDER’s handling of the Aduhelm approval, Cavazzoni’s memo reiterated FDA’s position that an internal assessment of review staff interactions with Biogen “found the Center’s interactions to be appropriate. Interacting with sponsors is a necessary component of our review work that helps ensure we have adequate information to inform our regulatory decision-making. That said, we have already started making changes consistent with the committees’ recommendations, including examining the use of a joint advisory committee’s briefing documents; ensuring complete documentation of substantive interactions in our \[Document Archiving, Reporting, and Regulatory Tracking System\]DAARTS; and plans to update the draft guidance for industry relating to [Alzheimer’s Disease: Developing Drugs for Treatment](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/alzheimers-disease-developing-drugs-treatment-guidance-industy?ref=fdaweb.com), with the goal of continuing to further improve our drug review processes for these drugs.”

FDA’s approved labeling for lecanemab says the therapy is for use in patients with mild cognitive impairment or mild dementia stage of disease, the population in which the treatment was studied. “The labeling also states that there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment?ref=fdaweb.com) says.

Approval is based on clinical data showing that patients receiving lecanemab had “significant dose- and time-dependent reduction of amyloid beta plaque,” compared to the placebo arm, which had no such reduction, the agency says. It also notes that results of a Phase 3 randomized, controlled clinical trial to confirm the drug’s clinical benefit have recently been reported and the agency anticipates receiving the data soon ([see earlier story](https://www.fdaweb.com/eisai-biogen-report-promising-alzheimers-data/)).

Additionally, lecanemab’s prescribing information includes a warning for amyloid-related imaging abnormalities (ARIA), which are known to occur with this drug class. “ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain, though some people may have symptoms such as headache, confusion, dizziness, vision changes, nausea and seizure,” FDA says.