Stephanie Fox-Rawlings, National Center for Health Research: August 8, 2018
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Stephanie Fox-Rawlings. Our center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.
We greatly support the efforts to develop new antibacterial drugs that will be effective resistant pathogens. However, the data reviewed by the FDA indicates that omadacycline may not be as safe and effective as a drug currently on the market for some groups of patients.
In the clinical trial comparing the effect of omadacycline to moxifloxacin to treat pneumonia, omadacycline potentially did not work as well or perhaps as quickly for older or sicker patients and patients with conditions like lung disease, bacteremia, or diabetes. The study used a population with varying underlying conditions, but because of this there were small numbers of patients in these important groups. But these are patients who tend to have more fragile health so they especially need safe and effective treatment.
Also, in this study there were more deaths of patients who took omadacycline compared to moxifloxacin. Again this affected patients with more serious infection, older patients, and patients with chronic conditions. As you all know, other antibiotics have been found to have severe systemic effects, including harming cardiac health, but those serious adverse events were not determined until years after they were widely prescribed. Many patients were seriously harmed as a result. For that reason, the number of deaths and other serious adverse events for this drug needs to be carefully analyzed and any increased risk would need to be included in the label if the product is approved. This is especially true since this drug is not shown to be superior to moxifloxacin for patients on average.
Two final points that may affect generalizability here in the US and brought up by the panel. First, analysis of racial diversity in the clinical trials is important because Limited diversity can raise questions about generalizability. And finally , there were few patients from North America. differences in medical practice could affect the safety and efficiency of use in the US.
In summary, if omadacycline is no better than some drugs on the market, and may be less safe or less effective for older patients, those with more serious infections, and patients with diabetes and lung disease, it is important to conduct further studies to know whether they should be excluded from the indication or not.