FNIH Biomarkers Consortium Provides Recommendations to FDA to Facilitate Drug Development for Serious Bacterial Infections

July 20, 2017 – The Foundation for the NIH (FNIH) Biomarkers Consortium (BC) has met a critical milestone that could improve clinical trials and accelerate treatment approvals for hospital-acquired bacterial infections. Upon request from the U.S. Food and Drug Administration (FDA), the FNIH submitted recommendations to the FDA to guide drug development for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). The FDA will consider the recommendations as it develops clinical trial guidance for these serious infections that lead to increased deaths while patients are in the hospital.

To develop the recommendations, the BC convened a project team that includes experts from the National Institute of Allergy and Infectious Diseases (NIAID), the FDA, not-for-profit organizations and pharmaceutical companies. The team analyzed 10 modern clinical trial data sets and reviewed more than 1,000 citations to develop, test and refine the set of recommendations that outline new, improved HABP/ VABP clinical trial endpoints (outcomes measured to determine whether a treatment being studied is beneficial).

This submission follows ongoing efforts by the BC to assist the FDA in developing new clinical trial guidance. In particular, the FDA recently updated guidance based on the BC’s recommendations for endpoints in clinical trials of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Thus far, four antibiotic drugs have been approved based on this revised guidance.

The results of the HABP/VABP Project enabled the FNIH to partner with ICON plc. to develop a patient reported outcome (PRO) tool to assess the symptoms of HABP at various time points over the course of the infection. The PRO tool is being validated in hospitals across the United States. This effort builds on similar PRO instrument development for CABP and ABSSSI. The BC anticipates that its recommendations and the PRO tool will help design more efficient clinical trials and streamline the drug approval process.

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Partners

Achaogen, Inc.
Actelion Pharmaceuticals Ltd.
American Thoracic Society
AstraZeneca Pharmaceuticals LP
Basilea Pharmaceutica International Ltd.
Bayer HealthCare Pharmaceuticals Inc.
Food and Drug Administration
ICON plc.
InClin
Infectious Diseases Society of America
The Medicines Company
Melinta Therapeutics
Merck Sharp & Dohme Corp.
Nabriva Therapeutics AG
National Institute of Allergy and Infectious Diseases (NIAID)
Pfizer Inc.
Roche
Shionogi Inc.
Talbot Advisors, LLC
Tetraphase Pharmaceuticals
Theravance Biopharma
Universitat de Barcelona

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