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Zanamivir (Glaxo Wellcome).

J S Oxford1

  • 1Retroscreen Ltd, Royal London School, 64 Turner Street, London, E1 2AD, UK. j.s.oxford@retroscreen.com

Idrugs : the Investigational Drugs Journal
|August 16, 2005
PubMed
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Zanamivir, a neuraminidase inhibitor, is an inhaled treatment for influenza. Despite initial FDA concerns, it gained approval for treating influenza A and B, launching globally and showing promising sales forecasts.

Area of Science:

  • Pharmacology
  • Virology
  • Drug Development

Background:

  • Zanamivir is a neuraminidase inhibitor developed by Glaxo Wellcome for influenza treatment.
  • Administered via inhaler directly to the respiratory tract, minimizing systemic side effects.
  • Neuraminidase inhibitors are considered technically vaccines, working by stimulating an immune response to prevent viral spread.

Purpose of the Study:

  • To document the development, regulatory approval, and market launch of zanamivir (Relenza).
  • To track the drug's progress through regulatory bodies including the FDA and Canadian HPB.
  • To report on market reception and sales predictions for zanamivir.

Main Methods:

  • Review of regulatory submissions and approvals in various countries (Australia, New Zealand, UK, US, Canada, Japan, Europe).

Related Experiment Videos

  • Monitoring of FDA advisory committee meetings and discussions regarding zanamivir's approval.
  • Analysis of financial market predictions for zanamivir sales.

    • Main Results:

    • Zanamivir (Relenza) launched in multiple countries, including the US in October 1999.
    • Received FDA approval for influenza A and B treatment in July 1999 after initial advisory committee concerns.
    • Canadian Health Protection Branch approval granted in November 1999.
    • Sales forecasts varied, with some predicting up to US$400 million by 2003.

    Conclusions:

    • Zanamivir successfully navigated regulatory hurdles to become a globally available influenza treatment.
    • The drug's inhaled administration offers a targeted approach to influenza therapy.
    • Despite initial regulatory challenges, zanamivir demonstrated significant market potential and sales expectations.