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Measuring progress in neglected disease drug development.

Joshua P Cohen1, Greg Sturgeon1, Alisa Cohen1

  • 1Tufts Center for the Study of Drug Development, Boston, Massachusetts.

Clinical Therapeutics
|June 8, 2014
PubMed
Summary
This summary is machine-generated.

Product Development Partnerships (PDPs) funding has increased neglected disease drug development, showing more approvals and Phase III products. However, progress is uneven, with limited new molecular entities and slow inclusion on essential drug lists.

Keywords:
World Health Organisationessential drug listneglected diseasesproduct development partnerships

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Area of Science:

  • Pharmaceuticals and Health Sciences
  • Global Health
  • Drug Development

Background:

  • Increased funding for neglected disease drug development since the late 1990s via Product Development Partnerships (PDPs).
  • Previous research indicated modest gains in drug approvals and Phase III products between 2000-2008.

Purpose of the Study:

  • Assess 2009-2013 neglected disease drug development, including Phase III products and approvals.
  • Calculate PDPs' share of new drug approvals.
  • Identify 2000-2013 approvals listed on the World Health Organization's Essential Drug List (EDL).

Main Methods:

  • Searched ClinicalTrials.gov, IMS R&D Focus, and Investigational Drugs Database for 2009-2013 neglected disease products.
  • Identified new drug approvals and Phase III products.
  • Determined inclusion of 2000-2013 approvals on the EDL.

Main Results:

  • 20 new neglected disease drug approvals in 2009-2013; PDPs sponsored 57%.
  • Annual average approvals rose from 2.6 (2000-2008) to 4.9 (2009-2013).
  • 18 products in Phase III development; 44% of 2000-2013 approvals are on the EDL.

Conclusions:

  • Increased PDP funding correlates with rising neglected disease drug approvals and Phase III products.
  • Uneven progress noted, with few new molecular entities and limited EDL inclusion.
  • PDPs should enhance access and work with WHO on clinical and cost-effectiveness assessments.