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Leflunomide Aventis Pharma.

M J Kaplan1

  • 1University of Michigan Medical Center, Division of Rheumatology, Ann Arbor 48109-1065, USA. makaplan@umich.edu

Current Opinion in Investigational Drugs (London, England : 2000)
|January 31, 2002
PubMed
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Leflunomide, an immunomodulator, was approved for rheumatoid arthritis treatment in the US and EU. This disease-modifying antirheumatic drug (DMARD) shows potential for transplant rejection and multiple sclerosis prevention.

Area of Science:

  • Pharmacology
  • Immunology
  • Rheumatology

Background:

  • Leflunomide (HWA-486) is an immunomodulator and disease-modifying antirheumatic drug (DMARD).
  • It was developed by Hoechst Marion Roussel (HMR), now Aventis Pharma.
  • Rheumatoid arthritis (RA) is a significant unmet medical need with a large potential market.

Purpose of the Study:

  • To detail the development and regulatory approval of leflunomide for rheumatoid arthritis.
  • To explore the preclinical investigation of leflunomide for transplant rejection and multiple sclerosis.
  • To highlight the drug's market potential and strategic importance.

Main Methods:

  • Regulatory filings and approvals in the US and EU for RA treatment.
  • Preclinical studies in animal models (e.g., EAE) for immunosuppressive potential.

Related Experiment Videos

  • Pharmacokinetic analysis of leflunomide's active metabolite (A-771726).

    • Main Results:

    • Leflunomide received FDA approval for active RA in 1998 and EU approval in 1999.
    • The drug was launched across the US, Latin America, and major European countries.
    • Preclinical studies indicated leflunomide as a potent immunosuppressant with potential in multiple sclerosis and transplant rejection.
    • A pregnancy registry was recommended due to potential teratogenic effects.

    Conclusions:

    • Leflunomide is an approved DMARD for RA with significant market presence.
    • Its immunosuppressive properties suggest therapeutic potential beyond RA.
    • Further monitoring for side effects, particularly teratogenicity, is warranted.