FDA Issues Guidance On Pneumonia Drug Development
By Cyndi Root
The Food and Drug Administration (FDA) announced guidance for pharmaceutical companies developing pneumonia drugs. The draft guidance “Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment” is available for public review. The advice adds to and revises the previous guidance issued in 2009. The agency offers this information to clinical investigators and drug sponsors involved in developing drugs for community-acquired bacterial pneumonia (CABP). The FDA acknowledges that clinical trial designs have improved over the years and the guidance shares the improvements. Additionally, the agency seeks feedback in several areas of pneumonia drug development.
Community-Acquired Bacterial Pneumonia
CABP is a bacterial infection of the pulmonary parenchyma. Symptoms include rigor, chills, chest pain, cough, fever, and difficulty breathing. Chest radiographs may show new lobar or multi-lobar infiltrates. Pathogens that cause CABP include Haemophilus influenza, Streptococcus pneumonia, Moraxella catarrhalis, and Staphylococcus aureus. Other bacterial pathogens that are more atypical include
Chlamydophila pneumoniae, Legionella pneumophila, and Mycoplasma pneumonia. CABP occurs commonly in the U.S. and is the sixth leading cause of death.
Feedback on Pneumonia Drug Development
Part of the draft guidance is a call to action. The FDA specifically requests that researchers and sponsors comment on critical areas of clinical investigations. The agency seeks with this feedback to balance practicality with effective research methods. Comments are requested on several measures including efficacy endpoints, the intent-to-treat (ITT) population, and antibacterial use by therapy patients before the trial:
- The agency seeks ways to enroll subjects that have received prior antibacterial therapy.
- Researchers are asked to describe two efficacy endpoints: 1) an improvement in patient symptoms at day three, four, and five; 2) an all-cause mortality.
- Submit suggestions on: 1) the overall intention-to-treat population; 2) a population of patients with a documented bacterial pathogen known to cause CABP.
- Non-inferiority margin experiments based on clinical responses.
About Draft Guidance
The FDA issues draft guidance in accordance with regulations (21 CFR 10.115). When the draft is finalized, it will represent the agencies up-to-date position. It is not binding on the FDA, drug developers, or the public. Interested parties can comment on the guidance before April 10, 2014, when the agency begins work on the final version.