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Related Experiment Videos

Drotrecogin alfa Eli Lilly.

E de Jonge1

  • 1Department of Intensive Care, Academic Medical Center, Meibergdreef 9, Postbus 22660, 1100 DD, Amsterdam, The Netherlands. e.dejonge@amc.uva.nl

Idrugs : the Investigational Drugs Journal
|November 27, 2004
PubMed
Summary
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Drotrecogin alfa (Xigris) is an anticoagulant approved for severe sepsis treatment in high-risk adults. This recombinant activated protein C aims to reduce mortality in sepsis patients.

Area of Science:

  • Pharmacology and Therapeutics
  • Critical Care Medicine
  • Drug Development and Regulation

Background:

  • Sepsis is a life-threatening condition requiring effective treatment options.
  • Drotrecogin alfa, a recombinant activated protein C, was developed as an anticoagulant therapy.
  • Eli Lilly & Co. pursued regulatory approval for drotrecogin alfa (Xigris) for sepsis treatment.

Purpose of the Study:

  • To document the regulatory and market launch process of drotrecogin alfa (Xigris).
  • To highlight the clinical application of drotrecogin alfa in severe sepsis.
  • To provide an overview of the drug's approval timeline and market introduction.

Main Methods:

  • Review of regulatory filings and approvals by the FDA and EMEA.
  • Tracking of brand name changes and rationale (Zovant to Xigris).

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  • Monitoring of FDA review status, including Priority Review and extended action dates.
  • Analysis of FDA Advisory Committee recommendations and approval conditions.

    • Main Results:

    • Drotrecogin alfa (Xigris) received FDA approval in November 2001 for reducing mortality in severe sepsis.
    • The drug was launched in the US market shortly after FDA approval.
    • Initial market predictions were significantly revised following the FDA's approval process and split committee decision.

    Conclusions:

    • Drotrecogin alfa (Xigris) became a significant therapeutic option for severe sepsis.
    • The regulatory pathway involved careful review and specific conditions for approval.
    • The drug's market introduction marked a key development in critical care for sepsis management.