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Pegvisomant. Pharmacia.

Vincent Goffin1, Philippe Touraine

  • 1INSERM, Unité 344, Faculté de Médecine Necker, Paris, France. goffin@necker.fr

Current Opinion in Investigational Drugs (London, England : 2000)
|July 2, 2002
PubMed
Summary

Pegvisomant, a growth hormone receptor antagonist, is being developed for acromegaly. Orphan Drug status was granted in the US, EU, and Japan, with regulatory filings and anticipated market launch in 2003.

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Area of Science:

  • Endocrinology
  • Pharmacology

Background:

  • Pegvisomant, a PEGylated derivative of human growth hormone (GH), functions as a selective GH receptor antagonist.
  • Pharmacia (formerly Sensus) is developing pegvisomant for acromegaly treatment.
  • The drug has received Orphan Drug status from the FDA, EU, and Japan, indicating potential for rare disease treatment.

Purpose of the Study:

  • To evaluate pegvisomant as a potential therapeutic agent for acromegaly.
  • To assess the regulatory progress and market potential of pegvisomant.
  • To explore earlier investigations into pegvisomant for diabetic complications, though development appears halted.

Main Methods:

  • Regulatory submissions including New Drug Application (NDA) for acromegaly.
  • Phase I and Phase II clinical trials for diabetes-related conditions (retinopathy, nephropathy, insulin sensitivity).
  • Licensing agreements for technology development (GH receptor antagonists, PEGylation).

Main Results:

  • NDA submitted for acromegaly; an approvable letter with outstanding issues was received.
  • Orphan Drug designation granted by FDA, EU, and Japan; Priority Review designation by FDA.
  • Earlier trials for diabetic retinopathy, nephropathy, and type II diabetes were initiated but lack recent development reports.

Conclusions:

  • Pegvisomant shows promise for acromegaly, with significant regulatory milestones achieved.
  • Acquisition of Sensus by Pharmacia streamlined development and commercialization efforts.
  • Market launch projected for 2003, with significant revenue forecasts, despite outstanding regulatory issues.

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