FDA Approves Updated Donanemab Labeling, BLA Accepted for Tividenofusp Alfa, Nipocalimab Outperforms FcRn Blockers

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Welcome to this special edition of Neurology News Network. I'm Marco Meglio.

According to a new announcement from Eli Lilly, the FDA has approved an updated label for donanemab (Kisulna), an FDA-approved therapy for early-stage Alzheimer disease (AD), to now include a new recommended titration dosing schedule, which may lead to lowered risk of amyloid-related imaging abnormalities (ARIA). Donanemab, an amyloid-targeting treatment, was approved in 2024 for patients with mild dementia stage of early AD with confirmed amyloid pathology. At the time, the recommended dosage of the therapy was 700 mg administered intravenously over approximately 30 minutes every 4 weeks for the first 3 doses, followed by 1400 mg every 4 weeks. In the latest updated labeling, the new recommended dosing regimen involves a more gradual titration, while still preserving the drug’s effect on amyloid plaque removal and phosphorylated tau 217 (p-tau) reduction.

The FDA has accepted Denali Therapeutics’ biologics license application (BLA) for tividenofusp alfa, an investigational agent, as a potential treatment for Hunter syndrome, a rare genetic lysosomal disease. Along with granting priority acceptance review, the agency assigned a PDUFA date of January 5, 2026, for the iduronate-2-sulfatase (IDS)-targeting therapy. Hunter syndrome results from a lack of the IDS enzyme, causing harmful sugar buildup throughout the body and brain in early childhood. Existing treatments can't reach the brain, leaving cognitive and behavioral symptoms unaddressed. Tividenofusp alfa, a next-gen therapy, aims to overcome this by delivering IDS across the blood-brain barrier using Denali’s TransportVehicle™ platform.

Newly presented data from an indirect treatment comparison of the phase 3 Vivacity-MG3 study (NCT04951622) at the 2025 European Academy of Neurology (EAN) Congress, held June 21-24, in Helsinki, Finland, revealed consistent and sustained efficacy with nipocalimab (Imaavy; Johnson & Johnson’s), an FDA-approved treatment for generalized myasthenia gravis (gMG), compared with other approved FcRn blockers. In the analysis, nipocalimab showed a comparable onset of symptom relief at 1-week and displayed greater or statistically significant improvement in Myasthenia Gravis-Activities of Daily Living (MG-ADL) scores when compared with published phase 3 data of other marketed FcRn blockers at different time points up to 24 weeks on treatment. Researchers reported that these findings were consistent across multiple indirect treatment comparison approaches.

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