EMA Issues Guidance on Antibiotic Development

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The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.


The European Medicines Agency (EMA) has released a guideline on the development of antibiotics, specifically on the use of pharmacokinetics and pharmacodynamics analyses to facilitate and speed up the development of new antibiotics. According to EMA, bacteria have become increasingly resistant to a wide range of antibiotics, and while it is essential for antibiotics to be used prudently, new antibiotics are needed for the treatment of serious infectious diseases. EMA plans on fighting antimicrobial resistance by offering an environment that stimulates and facilitates development of innovative antibiotics.

According to EMA, pharmacokinetics and pharmacodynamics analyses provide evidence about the appropriate dose and administration of an antibiotic to achieve the optimal benefit-risk balance. EMA defines pharmacokinetics as relating “to the effect the body has on a medicine; in other words how the medicine is absorbed by the body, distributed through the organs, transformed and finally excreted.” The agency defines pharmacodynamics as “the effect a medicine has on the body or on microorganisms or parasites; in the context of antibiotics, this relates to the ability of a medicine to kill or inhibit the growth of bacteria at a given dose.”


The analyses are conducted before clinical trials in humans and throughout the clinical development and, according to EMA, “have the potential to reduce the size of the clinical development program” and “are particularly crucial in the development of new antibiotics that address unmet medical needs or target multi-drug resistant bacteria since they contribute to streamlining and accelerating the development using innovative data-gathering strategies.”

The comment period for this guideline is open until March 31, 2016, and comments may be sent to IDWPsecretariat@ema.europa.eu.

Source: EMA