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U.S., EU and Japan Announce Progress on Antibacterial Research

November 19, 2019

The FDA, EMA and Japan’s Pharmaceuticals and Medical Devices Agency have made strides toward aligning clinical trial designs for antibacterial drug indications, the regulators announced following a tripartite meeting in Tokyo.

The agencies discussed differences between their test methods and interpretive criteria for susceptibility testing, also known as “breakpoints,” a chosen concentration of an antibacterial that defines if a species of bacteria is vulnerable or resistant to the drug, according to a report on the September meeting.

The regulators also discussed trial considerations for new types of treatment, such as monoclonal antibodies, and other non-traditional therapies for treating and preventing infectious diseases. Discussions were widened to include antifungal agents, an area of medicine that can be impacted by growing antimicrobial resistance and can face challenges in clinical development programs.

The regulators targeted pediatric development as an important part of developing antibacterial drugs and discussed ways to obtain pediatric clinical data and apply modeling and simulation.

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