EMA publishes guidance on anti-bacterials targeted against MDR pathogens

The European Medicines Agency (EMA) has released an addendum to the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections. It outlines a new approach facilitating the development of antibacterial agents targeted against multidrug-resistant (MDR) pathogens where patients have limited or no remaining treatment options. It also gives guidance on data-gathering strategies to support the benefit-risk evaluation as part of the marketing-authorization process for different indications.

This addendum complements the guideline on evaluation of medicinal products indicated for treatment of bacterial infections.

Guido Rasi, executive director of the EMA, said: “We urgently need new anti-bacterials to tackle the growing challenge of antimicrobial resistance. Infections by multidrug-resistant bacteria in the European Union are a major public health burden causing 25,000 extra deaths per year. One of our key activities in helping to bring these medicines to the market is to provide clear guidance for companies developing these medicines. With this addendum we are defining a new approach to facilitate the development of new anti-bacterials targeting multidrug resistance in areas where there are no or only limited therapeutic options. It marks an evolution in the way we think about bringing new antibiotics to patients.”