FDA Workshop: Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial (NTM) Disease

Posted on April 17, 2019   |   
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This blog post was written by Gretchen McCreary, Research Coordinator, COPD Foundation

The Food and Drug Administration (FDA) held a successful workshop on April 8, 2019 entitled, Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial (NTM) Disease. The workshop panelists included experts in their fields of NTM and Patient-Reported Outcomes (PROs). The goal of the workshop was to discuss clinical trial design related to the advancement of antibacterial therapies to treat NTM. Among the topics discussed, the panelists presented on and delved into the patient perspective for treatment of NTM, lessons learned from completed NTM trials and the implications for future trials, use of patient-reported outcome measures in NTM trials, as well as academic and industry perspectives on various case studies.

In preparation for this meeting, we worked closely with NTM Info & Research (NTMir) to collect valuable data via a short survey on patient experiences and preferences for NTM treatment. During the workshop, Amy Leitman of NTMir presented the survey results and shared your perspectives. There was a total of 465 responses to the survey. 92% of the survey respondents were female, with an average age of 65 years old. 84% of the survey respondents had been treated with antibiotics for an NTM infection, while 42% were currently being treated with antibiotics. The top symptoms that plagued survey respondents and had the greatest impact on their lives were fatigue, cough, shortness of breath, night sweats, and weight loss. When asked about their preferences in treatment outcomes, the majority of the respondents selected improving quality of life, increasing energy, and reducing fatigue.

We appreciate the FDA bringing together experts in the field of NTM disease to discuss these important issues. They are working together to listen to the patient voice and to help develop therapies to improve patients’ quality of life and relieve the chronic symptoms that impact you on a daily basis.

,p> The panelists’ slides, agenda and other meeting materials can be accessed here: https://www.fda.gov/Drugs/NewsEvents/ucm629494.htm.