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United States. Food and Drug Administration

Cox-2 Inhibitors Under Scrutiny: EU and US Regulators Examine Safety Risks

Strategic Insights

— 1 min read

As the world's largest drug manufacturers prepare for a tense week of regulatory scrutiny, the future of a widely used class of anti-inflammatory drugs, cox-2 inhibitors, hangs in the balance. The European Medicines Agency and the US Food and Drug Administration are set to deliver verdicts that could significantly impact the pharmaceuticals industry, with some analysts forecasting warnings on labels rather than outright removal from the market.

Key Takeaways:

  • The European Medicines Agency and the US Food and Drug Administration are re-examining the safety risks associated with cox-2 inhibitors, a class of anti-inflammatory drugs.
  • Analysts predict that regulators may ask for warnings on labels rather than remove the drugs from the market.
  • The cox-2 review underlines the debate over how to weigh a drug's relative benefit to many people against its risks of serious side-effects.
  • Regulators and drugmakers must balance science with public fears and risk tolerance.
  • Some experts argue that the pendulum has swung too far in the demonization of cox-2s, and regulators must manage the risk to conserve the value of the class.
  • New cox-2 drugs likely to face study on long-term use in people with low heart risk, adding to the development costs.
  • The withdrawal of Vioxx has resulted in estimated annual sales losses of $2.4bn for the next several years, significant litigation, and a decline in Merck's profits.
  • Analysts expect the combined Celebrex and Bextra sales of $4.6bn to halve this year.
  • GlaxoSmithKline remains confident in the development of its own new cox-2, 381, which is scheduled for an FDA submission in 2006.

Statistics:

  • Estimated annual sales losses for the next few years: $2.4bn (Merck)
  • Resolved legal fees for Merck: $675m
  • Expected sales of Arcoxia in 2009: $353m (down from $1.3bn)
  • Combined Celebrex and Bextra sales in 2004: $4.6bn
  • Projected combined Celebrex and Bextra sales in 2005: $2.3bn (halved)

Sources:

  • Evaluate, a London-based pharmaceuticals analysis group
  • Lehman Brothers
  • University of Pennsylvania
  • Pfizer
  • Merck
  • GlaxoSmithKline
  • FDA
  • European Medicines Agency

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