Wyeth-Ayerst Pharmaceuticals' ENBREL Receives European Approval for Rheumatoid Arthritis Treatment

Strategic Insights -

The European Medicines Evaluation Agency (EMEA) has approved Wyeth-Ayerst Pharmaceuticals' ENBREL (etanercept) for the treatment of active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate, has been inadequate. This approval comes after a positive opinion from the Committee on Proprietary Medicinal Products (CPMP) in November 1999. ENBREL, a significant therapeutic breakthrough in the treatment of rheumatoid arthritis, has become a well-accepted therapy by rheumatologists, with over 50,000 patients using the medication since its launch in the United States in November 1998.

Key Takeaways:

  • ENBREL, a biologic response modifier, has been approved by the EMEA for the treatment of active rheumatoid arthritis in adults who have not responded to conventional therapies.
  • The medication was jointly developed by Wyeth-Ayerst Pharmaceuticals and Immunex, and will be marketed in Europe in a staged manner.
  • ENBREL has shown significant improvement in health-related functionality, patient mental health, and vitality in clinical studies involving more than 1,800 rheumatoid arthritis patients.
  • The medication works by binding tumor necrosis factor (TNF), a dominant cytokine in the inflammatory process of rheumatoid arthritis, and reducing inflammation.
  • Wyeth-Ayerst Pharmaceuticals is investing in increasing production capacity to meet the growing demand for ENBREL, and the company anticipates making additional product available worldwide.
  • The most frequent adverse events reported in clinical trials were injection site reactions, infections, and headache, with malignancies being rare.
  • ENBREL should not be started in the presence of sepsis, infection, or allergy to the medication or its components.

Sources:

  • "PRNewswire" (Publication Date: Feb 7, 2000)
  • "European Medicines Evaluation Agency" (Source: EMEA, Committee on Proprietary Medicinal Products, Positive Opinion, November 1999)
  • "American Home Products Corporation" (Source: AHP Corporate Website, Press Release, February 2000)