Special Episode: FDA Approves Donanemab for Early Symptomatic Alzheimer Disease
Jul 09, 06:00 PM
Welcome to this special episode of the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. For major FDA decisions in the field of neurology, we release short special episodes to offer a snapshot of the news, including the main takeaways for the clinical community, as well as highlights of the efficacy and safety profile of the agent in question.
In this episode, we're covering the recent approval of donanemab as a new treatment for adults with early symptomatic Alzheimer disease (AD). Marketed as Kisunla, donanemab's approval marks the third antiamyloid therapy to get FDA greenlight for early-stage AD, following the controversial approval of aducanumab (Aduhelm; Biogen) in 2021 and lecanemab (Leqembi; Eisai) in 2023. Donanemab, administered as a 350 mg/20 mL once-monthly injection for intravenous infusion, had its approval supported by the phase 3 TRAILBLAZER-ALZ-2 trial (NCT04437511), a large-scale, double-blind, placebo-controlled trial that featured 1736 patients with early-stage AD. Following the approval, NeurologyLive sat down with Joel Salinas, MD, MBA, a behavioral neurologist at NYU Langone and clinical assistant professor in the department of neurology at the NYU Grossman School of Medicine. Salinas, who also serves as the chief medical officer at Isaac Health, discussed the positive impacts of the approval, the importance of patient selection for the medication, and how clinicians should discuss its benefits and harms to patients. In addition, he commented on how approvals like donanemab continue to carry momentum in the AD field going forward.
In this episode, we're covering the recent approval of donanemab as a new treatment for adults with early symptomatic Alzheimer disease (AD). Marketed as Kisunla, donanemab's approval marks the third antiamyloid therapy to get FDA greenlight for early-stage AD, following the controversial approval of aducanumab (Aduhelm; Biogen) in 2021 and lecanemab (Leqembi; Eisai) in 2023. Donanemab, administered as a 350 mg/20 mL once-monthly injection for intravenous infusion, had its approval supported by the phase 3 TRAILBLAZER-ALZ-2 trial (NCT04437511), a large-scale, double-blind, placebo-controlled trial that featured 1736 patients with early-stage AD. Following the approval, NeurologyLive sat down with Joel Salinas, MD, MBA, a behavioral neurologist at NYU Langone and clinical assistant professor in the department of neurology at the NYU Grossman School of Medicine. Salinas, who also serves as the chief medical officer at Isaac Health, discussed the positive impacts of the approval, the importance of patient selection for the medication, and how clinicians should discuss its benefits and harms to patients. In addition, he commented on how approvals like donanemab continue to carry momentum in the AD field going forward.
For more of NeurologyLive's coverage of donanemab's approval, head here: FDA Approves Eli Lilly's Donanemab for Early Symptomatic Alzheimer Disease
Episode Breakdown:
- 2:10 – Positive downstream impacts of donanemab's approval
- 4:20 – Considerations and caution with prescribing donanemab
- 6:05 – Salinas on patient-clinician conversations about AD treatments
- 8:00 – Closing remarks and continued progress in AD field
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