The Academy is pleased to continue its exploration of AMR and the need for new antibiotics. The EMA just released the final revised guideline on its evaluation of human medicines for the treatment of bacterial infections.

This document is an additional important step in the harmonization process among Regulatory Authorities, as the indications suggested in the guideline are valid not only for Europe, but also the United States and Japan.

In the foreword of the guideline you can read that “Antimicrobial Resistance (AMR) has a direct impact on the health of people and animals and carries a heavy economic burden worldwide. In the European Union (EU) alone, it is responsible for an estimated 33,000 deaths per year. It is also estimated that AMR costs the EU €1.5 billion per year in healthcare costs and productivity losses.”1

As was reported in April, research and development of new antibiotics has declined over the last two decades due largely to limited economic returns on the development of such medicines. 

The document includes:

  • clarifications on recommended clinical development programs for antimicrobials intended to address an unmet need;
  • guidance on clinical trials to support treatment of uncomplicated urinary tract infections and uncomplicated gonorrhea;
  • updated guidance on displaying microbiological and clinical efficacy data in the summary of product characteristics.

The revised guideline is published together with an addendum aiming to steer clinical development programs required to support the authorization of medicines for treatment of bacterial infections in children. For the treatment of some infections, efficacy results can be extrapolated in certain children age groups by looking at efficacy data from adults. The addendum mentions that companies developing new antibiotics need to develop an extrapolation concept and provide details about it in an extrapolation plan. For some infections that occur only or mostly in children below a certain age, extrapolating efficacy data from adults is not possible. The addendum includes guidance on trials that may be conducted in these exceptional cases.

You can read the full text of the guideline here.

Disclaimers

  • The material in these reviews is from various public open access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred

References

  1. EMA guidance supports development of new antibiotics. (2022, May 24). European Medicines Agency. https://www.ema.europa.eu/en/news/ema-guidance-supports-development-new-antibiotics#:%7E:text=As%20part%20of%20its%20efforts,the%20treatment%20of%20bacterial%20infections.
  2. Addendum to the guideline on evaluation of medicinal products indicated for treatment bacterial infections address paediatric-specific clinical data requirements. (2022, May 24). European Medicines Agency. https://www.ema.europa.eu/en/addendum-guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-address