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Expanding indications for biotechnology agents

P Piascik1

  • 1University of Kentucky College of Pharmacy, Lexington, USA.

American Pharmacy
|April 1, 1995
PubMed
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Biotechnology drugs initially approved for rare diseases are now finding new uses in larger patient populations. This expansion offers novel therapeutic options for conditions lacking effective treatments.

Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Drug Development

Background:

  • Many biotechnology products gain initial approval for limited patient groups.
  • Pharmaceutical companies actively research expanded therapeutic applications for existing drugs.

Purpose of the Study:

  • To analyze the trend of biotechnology drugs gaining multiple indications.
  • To highlight the impact of expanded drug approvals on patient populations.

Main Methods:

  • Review of drug approval databases.
  • Analysis of post-marketing studies.
  • Examination of therapeutic area expansion for biotechnology agents.

Main Results:

  • Several biotechnology agents initially approved for rare diseases are now approved for multiple indications.

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  • These expanded approvals serve significantly larger patient populations.
  • Biotechnology drugs are increasingly utilized in cases where prior therapies were ineffective.

    • Conclusions:

    • The development pathway for biotechnology products often involves expanding indications beyond initial approvals.
    • This trend broadens treatment accessibility and addresses unmet medical needs.
    • Continued research into biotechnology agents is crucial for discovering new therapeutic uses.