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Ligelizumab

Brand and Other Names: Ligelizumab
Mechanism of Action:
Indications:
Route:
Dose:
Adverse Reactions:
 
 

 

Contraindication:
Warnings and Precautions:
Description:

Not FDA‑approved; in Phase 3 trials, Breakthrough designation  

GOOGLE OVERVIEW

Ligelizumab is a high-affinity humanized monoclonal antibody being developed to treat chronic spontaneous urticaria (CSU), also known as chronic hives, and other conditions. It works by blocking immunoglobulin E (IgE), a key component in the inflammatory process of CSU. While it has shown promising results in clinical trials, including being superior to placebo and similar to omalizumab in some studies, it has not yet been approved by the FDA for CSU. 
 
Here's a more detailed breakdown:
What it is:
  • Ligelizumab is a next-generation anti-IgE antibody, meaning it binds to IgE with high affinity, potentially leading to more effective blocking of the IgE pathway. 
     
It's designed to treat CSU, a condition where hives appear without a known cause. 
 
It's administered as a subcutaneous injection.
 
How it works:
IgE plays a crucial role in the inflammatory response that causes CSU symptoms like itching and swelling.
Ligelizumab works by binding to IgE, preventing it from triggering the inflammatory cascade. 
 
Clinical Trials and Results:
Phase 2 trials showed ligelizumab to be more effective than both placebo and omalizumab (a currently available anti-IgE treatment) in reducing CSU symptoms. 
 
Phase 3 trials, including the PEARL studies, demonstrated that ligelizumab was superior to placebo but not significantly different from omalizumab in terms of efficacy. 
 
While the Phase 3 results did not show ligelizumab to be superior to omalizumab, the studies did confirm the efficacy of ligelizumab in improving CSU symptoms and quality of life. 
 
Ligelizumab has also been shown to be well-tolerated, with a safety profile similar to omalizumab. 
 
Current Status:
Ligelizumab has received FDA Breakthrough Therapy designation for CSU, indicating its potential to offer substantial benefit over existing treatments. 
 
Despite the positive clinical trial results, the development of ligelizumab for CSU has been halted. 
 
However, it is still being evaluated for other potential uses, including food allergy, according to ScienceDirect.com.
See package insert for full prescribing information.