FDA finalizes bacterial pneumonia drug development guidances

Regulatory NewsRegulatory News | 24 June 2020 |  By 

The US Food and Drug Administration (FDA) on Wednesday finalized two guidances on developing drugs to treat community-acquired or hospital-acquired and ventilator-associated bacterial pneumonia.
 
Both guidances offer recommendations to sponsors on the development of drugs to treat bacterial pneumonia acquired in different settings and feature input on nonclinical development, trial population, efficacy trial considerations and other issues including pharmacokinetic/pharmacodynamic and labeling considerations.
 
The final guidances come a decade after draft versions were released, in 2009 for community-acquired bacterial pneumonia (CABP) and in 2010 for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). Both draft guidances were revised in 2014.
 
FDA says the publication of the final guidances fulfills part of its requirement to revise three or more guidances each year related to the clinical development of antibacterial and antifungal drugs under the Food and Drug Administration Safety and Innovation Act.
 
In its guidance on CABP, FDA says it revised its recommendations to clarify when to assess the primary efficacy endpoint and to include discussion about the evaluation of intravenous drug formulations.
 
The guidance on HABP and VABP features revised recommendations on randomization and considerations for whether to enroll patients who have received prior antibacterial drug therapy in clinical trials.
 
Both final guidances include updates to the respective trial populations and a discussion of statistical considerations for analysis populations.

 

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