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Cladribine. Ortho Biotech Inc.

C Tortorella1, M Rovaris, M Filippi

  • 1Neuroimaging Research Unit, Department of Neuroscience, Scientific Institute and University Ospedale San Raffaele, Milan, Italy.

Current Opinion in Investigational Drugs (London, England : 2000)
|March 15, 2002
PubMed
Summary

Cladribine, an adenosine deaminase inhibitor, is approved for treating various cancers and was investigated for multiple sclerosis (MS). Clinical study issues led to a withdrawn NDA for MS treatment.

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Area of Science:

  • Pharmacology and Drug Development
  • Oncology
  • Neurology

Background:

  • Cladribine, an adenosine deaminase inhibitor, has been utilized for treating several neoplasms since its US launch in 1993.
  • The compound's potential for treating multiple sclerosis (MS) was explored by Ortho Biotech and The Scripps Research Institute.

Purpose of the Study:

  • To evaluate cladribine's efficacy and safety for multiple sclerosis (MS) treatment.
  • To seek regulatory approval for cladribine in managing relapsing-remitting and secondary progressive MS.

Main Methods:

  • Development and submission of a New Drug Application (NDA) to the FDA for cladribine in MS.
  • Clinical studies were conducted to assess cladribine's therapeutic potential in MS patients.

Main Results:

  • An FDA inspection identified violations in clinical studies for cladribine's MS indication.
  • Ortho Biotech withdrew the NDA for MS, necessitating further clinical studies.

Conclusions:

  • Cladribine has established applications in treating various leukemias and lymphomas.
  • Development for MS faced setbacks due to clinical trial compliance issues, requiring further investigation.

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