FDA finalizes bacterial pneumonia drug development guidances

FDA has finalized two guidances on developing drugs to treat bacterial pneumonia. Both guidances offer recommendations on the development of drugs to treat bacterial pneumonia acquired in different settings: community-acquired bacterial pneumonia (CABP) and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

FDA has finalized two guidances on developing drugs to treat bacterial pneumonia. Both guidances offer recommendations on the development of drugs to treat bacterial pneumonia acquired in different settings: community-acquired bacterial pneumonia (CABP) and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). The final guidances feature input on nonclinical development, trial population, efficacy trial considerations and other issues. In its guidance on CABP, FDA says it revised its recommendations to clarify when to assess the primary efficacy endpoint and cover the evaluation of I.V. drug formulations. The guidance on HABP and VABP includes new recommendations on randomization and considerations for whether to enroll patients who have received prior antibacterial drug therapy in clinical trials.