Newly Approved Donanemab Brings Another Treatment Option for Alzheimer Disease: Joel Salinas, MD, MBA

WATCH TIME: 7 minutes

"My clinical perspective is to be cautious in determining who is a good choice for this medication, and part of it is doing a standardized and thorough evaluation, making good use of healthcare resources in terms of when we do advanced imaging and any other [tests]. But more than anything, I would say, is to really engage in that shared and supported decision making with the patient and the family."

Earlier this month, the FDA approved donanemab (Kisunla; Eli Lilly and Company) as a 350 mg/20 mL once-monthly injection for intravenous infusion for the treatment of adults with early symptomatic Alzheimer disease (AD).¹ The treatment is available to patients with mild cognitive impairment and those with the mild dementia stage of AD, with confirmed amyloid pathology. Considered the third approved antiamyloid therapy, donanemab is the first and only medication with evidence to support stopping treatment when amyloid plaques are removed, which can result in lower therapy costs and fewer infusions.

The approval was supported by data from the phase 3 TRAILBLAZER-ALZ-2 trial (NCT04437511), which featured 1736 patients with early-stage AD who received either donanemab (n = 860) or placebo (n = 876) every 4 weeks for up to 72 weeks. In the low/medium tau population, least-square mean change from baseline in the integrated Alzheimer Disease Rating Scale score at 76 weeks was –6.02 (95% CI, ­–7.01 to –5.03) in the donanemab group and ­–9.27 (95% CI, –10.23 to ­–8.31) in the placebo group, resulting in a 35.1% (95% CI, 19.90-50.23) slowing of disease progression. The impacts were less pronounced in the overall population, with between-group score differences of 2.92 (95% CI, 1.51-4.33; P <.001), representing a 22.3% (95% CI, 11.38-33.15) slowing of disease progression.²

Following the news, Joel Salinas, MD, MBA, a behavioral neurologist at NYU Langone Health and the chief medical officer at Isaac Health, sat down with NeurologyLive^® in an interview to share his clinical perspective of how the approval of this new AD drug will impact early detection and diagnosis of the disease in future research. He also talked about the challenges that healthcare providers face in determining the suitability of this medication for individual patients. Furthermore, Salinas spoke about how healthcare systems can support patients and families in navigating the complexities introduced by new AD treatments.

REFERENCES
1. Lilly's Kisunla™ (donanemab-azbt) Approved by the FDA for the Treatment of Early Symptomatic Alzheimer's Disease. News Release. Eli Lilly. Published July 2, 2024. Accessed July 2, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early
2. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. Published online July 17, 2023. doi:10.1001/jama.2023.13239