To help support a global approach to developing new drugs that address antimicrobial resistance, the European Medicines Agency (EMA) has published a final guideline aimed at aligning data requirements with other countries’ regulators.

The EMA guideline harmonizes with plans established among regulators in the EU, the U.S. and Japan, including revised recommendations for primary endpoints, primary analysis populations and noninferiority margins in trials to support certain infection site-specific indications for use.

The document also includes clarifications on recommended clinical development programs for antimicrobials developed to address an unmet need,
as well as guidance on clinical trials to support treatment of uncomplicated
urinary tract infections and uncomplicated gonorrhea.

A new addendum to the guideline addresses drug development programs aimed at pediatric populations. For the treatment of some infections, the EMA said that efficacy results can be extrapolated in certain pediatric age groups by looking at efficacy data from adults.

Read the EMA guidance here: https://bit.ly/3NUIeux.

Read the pediatric addendum here: https://bit.ly/3zgaF20.