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Darbepoetin alfa. Amgen.

F Locatelli1, L D Vecchio

  • 1A Manzoni Hospital, Department of Nephrology and Dialysis, Lecco, Italy. nefrologia@ospedale.lecco.it

Current Opinion in Investigational Drugs (London, England : 2000)
|March 15, 2002
PubMed
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Amgen launched Aranesp (darbepoetin alfa), a novel erythropoiesis stimulating protein, for anemia in renal disease patients. Approved in Europe in 2001, its global rollout and oncology trials are underway.

Area of Science:

  • Pharmacology
  • Biotechnology
  • Nephrology

Background:

  • Anemia is a common complication in patients with renal disease.
  • Erythropoiesis stimulating agents (ESAs) are used to treat anemia.
  • Darbepoetin alfa (NESP) is a novel synthetic recombinant ESA.

Purpose of the Study:

  • To announce the launch and regulatory status of darbepoetin alfa (Aranesp).
  • To provide an update on clinical trials and market rollout.
  • To highlight the commercial potential of darbepoetin alfa.

Main Methods:

  • Regulatory approval process in Europe and anticipated US approval.
  • Clinical trial phases (Phase I, pivotal, Phase III) in renal and oncology patients.
  • Commercialization strategy including licensing and distribution agreements.

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Main Results:

  • European Commission approval granted in June 2001 for anemia in chronic kidney failure.
  • Successful pivotal trial in oncology patients reported in January 2001.
  • Anticipated significant sales projections, exceeding $1.4 billion at maturity.

Conclusions:

  • Darbepoetin alfa (Aranesp) represents a significant advancement in anemia treatment for renal disease patients.
  • The drug's development pipeline includes oncology indications.
  • Strong market potential is projected based on early trial results and sales forecasts.