Jack Shuang Hou Shares Major Neurology Updates This Week
Jack Shuang Hou, Scientific Director at Jtests, shared on LinkedIn:
”FDA Approves Intrathecal Zolgensma, Ozempic Falls Short in EVOKE Trials, and Bayer Advances Stroke Therapy — Major Neurology Updates This Week
A big week in neurology with three notable regulatory and clinical updates spanning SMA, Alzheimer’s disease, and stroke prevention.
Here’s what stands out:
FDA Approves Intrathecal Novartis’ Itvisma (onasemnogene abeparvovec-brve)
The FDA has granted approval for the first intrathecal formulation of the SMA gene therapy Itvisma — expanding use to children, teens, and adults.
Key points:
• Provides a new route of administration vs. the original 2019 IV version
• Targets the SMN1 gene to restore SMN protein expression
• Broadens accessibility for patients with spinal muscular atrophy
A significant milestone for SMA care.
Novo Nordisk’s Oral Semaglutide (Ozempic) Fails to Slow Alzheimer’s Progression
Phase 3 EVOKE and EVOKE+ trials (n = 3,808) showed no superiority over placebo for slowing progression in early symptomatic AD.
However:
• Biomarker improvements were observed
• Safety profile consistent with prior data
• The extension phase of the trials will now be discontinued
A reminder of the complexity of Alzheimer’s disease and the gap between biomarker shifts and clinical outcomes.
Bayer’s Asundexian Hits Primary Endpoint in OCEANIC-STROKE Trial
The FXIa inhibitor met its primary endpoint in >12,300 patients with recent non-cardioembolic ischemic stroke or high-risk TIA.
Highlights:
• Reduced recurrent stroke risk when added to standard therapy
• Favorable safety profile
• Regulatory submissions expected soon
This positions asundexian as a potential next-generation anticoagulant with lower bleeding risk potential.
My Takeaway
These three updates collectively highlight:
• Ongoing gene therapy innovation reaching broader patient groups
• The persistent challenge of translating metabolic/GLP-1 pathways into Alzheimer’s therapeutics
• The rise of FXIa inhibition as a safer anticoagulation strategy for stroke prevention
The neurology field is rapidly evolving, and these developments underscore the importance of diversified RandD across genetics, metabolism, and precision clotting pathways.”
Read the full article here.
Article: FDA Approves Intrathecal Version of Zolgensma, Ozempic Falls Short in EVOKE Trials, Asundexian Meets End Point in Stroke Prevention Trial
Authors: NeurologyLive® Staff
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