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Pharmaceutical industry

SmithKline Beecham Defends Avandia Against Criticism

Strategic Insights

— 1 min read

SmithKline Beecham, the manufacturer of the diabetes medication Avandia (rosiglitazone maleate), has issued a statement defending the drug against criticism from the U.S. Food and Drug Administration (FDA) and other regulatory agencies. The statement, made by David Wheadon, MD, director of Regulatory Affairs - North America, at the FDA Endocrinology and Metabolic Advisory Committee meeting, emphasizes the safety and efficacy of Avandia in treating type 2 diabetes.

Key Takeaways:

  • SmithKline Beecham supports the FDA's position that glitazones, including Avandia, are valuable alternatives for patients with type 2 diabetes.
  • Since its approval, approximately three million prescriptions have been written for Avandia in the United States, with nearly one million patients treated.
  • Avandia leads the glitazone class in total prescriptions, with a post-approval experience similar to that seen in clinical studies.
  • An independent panel of hepatologists has reviewed data and found no cases of liver failure definitively attributed to Avandia.
  • The efficacy and hepatic safety profile of Avandia remains consistent with SmithKline Beecham's clinical trial experience and the type 2 diabetes population as a whole.
  • Key medical organizations have endorsed the FDA's position that glitazones are safe and effective alternatives for patients with type 2 diabetes.

Statistics:

  • Approximately 5,000 patients have been enrolled in SmithKline Beecham's clinical trial program for Avandia, with more than 5,500 patient years of exposure.
  • Three million prescriptions have been written for Avandia in the United States since its approval.
  • Nearly one million patients have been treated with Avandia in the United States.
  • Avandia leads the glitazone class in total prescriptions.

Sources:

  • Statement by David Wheadon, MD, director of Regulatory Affairs - North America, at the FDA Endocrinology and Metabolic Advisory Committee meeting.
  • Medical Letter on the CDC & FDA, May 2000 via NewsRx.com.

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