Eli Lilly and Company (NYSE: LLY) announced that Kisunla (donanemab), a novel medication for individuals with early-stage Alzheimer’s disease, has received marketing clearance from the European Commission (EC). Patients with moderate cognitive impairment or mild dementia who are in the early stages of neurodegenerative illness in the European Union now have a new treatment option thanks to this historic ruling.
Donanemab therapy significantly slowed the cognitive and functional decline of patients with early-stage Alzheimer’s disease, according to the Phase 3 TRAILBLAZER-ALZ 2 research. A more gradual titration of the dosage was linked to a lower incidence of amyloid-related imaging abnormalities (ARIA), a known adverse effect of this class of medications, according to the results of the TRAILBLAZER-ALZ 6 research.
Read More: Lilly’s Kisunla (Donanemab) Shows Long-Term Benefit in Treating Early Alzheimer’s Disease
Kisunla demonstrated meaningful results in people with early symptomatic Alzheimer’s disease by significantly slowing cognitive and functional decline in our Phase 3 TRAILBLAZER-ALZ 2 study,
The data shows that the earlier patients are identified, diagnosed, and treated with Kisunla, the greater the response to treatment. This authorization brings a new option to patients in Europe—offering hope and the potential for more time to focus on what matters most.
Patrik Jonsson
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Kisunla has received European approval exclusively for patients who are ApoE4 heterozygotes or non-carriers. This stands in contrast to approvals in other countries, including China, Japan, and the United States, where patients can receive the medication regardless of their ApoE4 genetic status. The ApoE4 gene has been linked to an increased risk of ARIA and is a known risk factor for Alzheimer’s disease.
Millions of people and their families across Europe are impacted by Alzheimer’s disease, which is a serious and expanding public health concern. With a treatment that can significantly alter the course of the disease, Kisunla’s approval represents a major advancement in the management of this debilitating condition.
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An intravenous infusion of Kisunla is given once a month. In order to guarantee that qualified patients can obtain this novel medicine, Eli Lilly and Company will collaborate with healthcare systems throughout the European Union. In the US, Japan, China, UK, and Australia, among other nations, donanemab is already marketed under the name Kisunla.
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Graduated from the University of Kerala'20 with B.Sc. Botany & Biotechnology. Post-graduation in Biotechnology from the University of Kerala'22. Internship experience in Cancer Research.
