The EMA publishes guidance on the development of NEW antibiotics

The EMA publishes guidance on the development of NEW antibiotics
  • The European Medicines Agency (EMA) has published a guide on the development of new antibiotics.
  • The text deals with issues related to antimicrobial resistance (AMR).
  • Additionally, it provides clarification on recommended clinical development schedules for antimicrobials intended to address an unmet need.

The European Medicines Agency (EMA, for its acronym in English) has published a guide on the development of new antibiotics in which, in addition, it deals with issues related to antimicrobial resistance (AMR, for its acronym in English), and that only in the European Union is it responsible for some 33,000 deaths a year.

Given this, the EMA plays an important role in the fight against AMR by guiding and supporting the development of new medicines and treatment approaches, especially for patients with infections caused by multiresistant bacteriawho currently have very few therapeutic options.

Since antimicrobial resistance is a global threatEU regulators, United States and Japan agreed to align their respective data requirements as much as possible so that drug developers can design clinical trials that meet the evidence needs of multiple regulatory agencies.

With more than 670,000 drug-resistant bacterial infections in the European Union alone and approximately 33,000 people dying as a direct consequence of these infections, its weight in healthcare is comparable to that of the flu, tuberculosis and HIV combined.

NEW antibiotics for these conditions

In this sense, the EMA document shows clarifications on the programs of clinical development recommendations for antimicrobials intended to address an unmet need; clinical trial guidance to support the treatment of uncomplicated urinary tract infections and uncomplicated gonorrhea; and updated guidance on displaying microbiological and clinical efficacy data in the summary of product characteristics.

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The revised guideline is published alongside an appendix intended to guide the clinical development programs necessary to support the authorization of medicines for the treatment of bacterial infections in children.

Some figures that made the researchers give voice to the fear of health professionals and scientists.

“Previous estimates had predicted 10 million annual deaths from antimicrobial resistance by 2050, but we now know for sure that We are already much closer to that number than we thought.” exactly pointed out.

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