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Updated: Feb 13, 2026
26:41
Perspectives on Neuroscience
Published on: July 31, 2007
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Natalizumab: Perspectives from the Bench to Bedside.
Afsaneh Shirani1, Olaf Stüve1,2
1Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, Texas 75390.
Cold Spring Harbor Perspectives in Medicine
|March 4, 2018
Summary
Natalizumab, a monoclonal antibody for multiple sclerosis, targets lymphocyte trafficking by blocking α4-integrin. Despite rapid development, its post-approval history includes withdrawal due to progressive multifocal leukoencephalopathy and subsequent reinstatement with strict monitoring.
Area of Science:
- Neuroimmunology
- Pharmacology
- Drug Development
Background:
- Natalizumab is a monoclonal antibody used to treat relapsing remitting multiple sclerosis.
- It functions by inhibiting lymphocyte trafficking into the central nervous system via α4-integrin blockade.
- The drug's development timeline from target discovery to approval was notably rapid.
Purpose of the Study:
- To provide a comprehensive overview of natalizumab's journey.
- To discuss its efficacy and safety profile.
- To highlight the challenges and successes in its post-marketing surveillance.
Main Methods:
- Review of scientific literature and regulatory documents.
- Analysis of clinical trial data and post-marketing surveillance reports.
- Examination of the mechanism of action and its clinical implications.
Main Results:
- Natalizumab demonstrated significant efficacy in reducing multiple sclerosis relapses.
- An unforeseen risk of progressive multifocal leukoencephalopathy (PML) emerged post-approval.
- Reintroduction of natalizumab was accompanied by risk mitigation strategies and patient monitoring.
Conclusions:
- Natalizumab represents a significant advancement in multiple sclerosis treatment.
- The drug's history underscores the importance of rigorous post-marketing surveillance.
- Careful patient selection and monitoring are crucial for managing the risks associated with natalizumab therapy.
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