JHVEPhoto/iStock Editorial via Getty Images The U.S. FDA on Thursday commented on Eli Lilly’s ( NYSE: LLY ) Alzheimer’s therapy donanemab ahead of a meeting on its marketing application, suggesting a safety warning for the anti-amyloid therapy to highlight its potential adverse events.
Donanemab, as well as Leqembi, the newly-approved Alzheimer’s therapy from Biogen ( BIIB ) and Eisai ( OTCPK:ESALF ) ( OTCPK:ESAIY ), are associated with suspected brain hemorrhages, manifested as amyloid-related imaging abnormalities (ARIA). The FDA noted that donanemab is also linked to other safety signals, infusion-related reactions, and hypersensitivity. “The risks can be described in the prescribing information, including a boxed warning concerning ARIA, recommendations regarding MRI monitoring, and a contraindication for serious hypersensitivity reactions,” the FDA staffers wrote in their briefing documents.
The FDA’s advisory panel on neurology drugs is expected to review their findings during a meeting scheduled to take place on Monday. Though advisory committees issue non-binding recommendations to the FDA, the regulator usually follows them before making a final decision on authorizations. More on Eli Lilly Is It Possible Eli Lilly Is Breaking Out To New All-Time Highs? Eli Lilly and Company (LLY) Lilly Oncology ASCO Investor Event (Transcript) Eli Lilly's Growth And Challenges: A Cautious Buy Eli Lilly snaps six straight days of gains, trades in the red Biogen favored at.
