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Eli Lilly And Co’s (NYSE:LLY) shares are trading higher after an advisory committee to the U.S. Food and Drug Administration (FDA) delivered a favorable verdict on the company’s Alzheimer’s treatment, donanemab, declaring its benefits to surpass the associated risks.
This experimental medication targets an early stage of Alzheimer’s disease, aiming to significantly alter the treatment landscape for patients.
The panel’s unanimous endorsement now propels the treatment toward a final FDA verdict, anticipated earlier this year but delayed to allow for the expert review, reported Reuters.
Dawn Brooks, Lilly’s development leader for donanemab, expressed satisfaction with the committee’s recognition of the drug’s favorable benefit-to-risk profile. With the panel’s backing, the focus shifts to the FDA’s comprehensive review of the treatment.
The FDA’s advisers deliberated on several unique aspects of Lilly’s clinical trials, contrasting sharply with Eisai Co Ltd (OTC:ESALF) and Biogen Inc’s (NASDAQ:BIIB) approaches for their Alzheimer’s drug, Leqembi, per the report.
Unlike Leqembi, Lilly’s strategy included measuring levels of tau, a protein linked to brain cell death, to determine patient eligibility within a 76-week study.
Also Read: Eli Lilly Shares Results From The SYNERGY-NASH Phase 2 Study
The panel discussed how Lilly excluded patients with minimal or no tau protein from its pivotal study but conducted separate analyses on this demographic in a larger trial, suggesting potential treatment benefits.
There was a consensus among the panelists that tau testing should not be prerequisite for treatment, to avoid limiting access for rural or underserved populations.
However, safety concerns were elevated for patients with dual copies of the APOE4 gene, linked to a higher Alzheimer’s risk, prompting discussions on the necessity of informed physician guidance regarding these risks.
In Lilly’s major trial, monthly infusions of donanemab slowed cognitive decline by 29%, closely mirroring the 27% efficacy of Leqembi.
However, significant side effects like brain swelling and bleeding were observed, affecting 24% and 31% of participants, respectively. Notably, three patients succumbed to these complications.
Lilly plans further trials, including among genetically predisposed populations like those with Down syndrome.
Price Action: LLY shares are trading higher by 2.08% at $883.00 in premarket at the last check Tuesday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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