The US Food and Drug Administration has granted approval for donanemab, a new treatment for Alzheimer’s disease developed by Eli Lilly. This approval follows extensive clinical studies demonstrating that the drug can significantly slow cognitive decline, marking a milestone after years of regulatory delays.
Donanemab, branded as Kisunla, will be administered as a monthly injection. Clinical trials spanning 18 months involved over 1,700 participants, stratified by early and advanced disease stages. Those treated with donanemab showed a 39% lower risk of disease progression compared to those on a placebo.
This marks the second FDA-approved drug for Alzheimer’s after lecanemab (Leqembi), approved in the previous year by Biogen and Eisai. The Alzheimer’s Association has hailed this decision, emphasizing the importance of early detection and treatment access.
Joanne Pike, Alzheimer’s Association president and CEO, described the approval as significant progress, offering more options and time for patients and caregivers impacted by the disease. She highlighted the need for equitable access to these treatments, urging healthcare providers and systems to be prepared to support patients effectively.
The Association encourages clinicians to participate in ALZ-NET, a network gathering real-world data on Alzheimer’s therapies’ effectiveness across diverse populations. Looking ahead, researchers aim to develop treatments targeting different aspects of the disease to further enhance outcomes.
Barbara Eades, diagnosed with mild cognitive impairment in 2018 and a participant in the clinical trial, expressed gratitude for the treatment, enabling her to continue living actively and passionately.
However, the Alzheimer’s Association expressed disappointment at the continued underrepresentation of affected populations, particularly Black/African Americans and Hispanic/Latino Americans, in clinical trials. They stressed the critical need for inclusive research to ensure treatments meet the needs of all communities affected by Alzheimer’s and related dementias.