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, which complements the Guideline on evaluation of medicinal products indicated for treatment of bacterial infections.
The addendum includes a new approach on developing antibacterial agents targeted against multidrug-resistant (MDR) pathogens where patients have very limited or no remaining treatment options. It also provides guidance on data-gathering strategies to support the benefit-risk evaluation as part of the marketing-authorization process for different indications.
“Infections by multidrug-resistant bacteria in the European Union are a major public health burden causing 25,000 extra deaths per year,” said Guido Rasi, Executive Director of the EMA, in a press statement . “We urgently need new antibacterials to tackle the growing challenge of antimicrobial resistance. 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 antibacterials 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.”
The addendum provides recommendations on:
clinical development for medicines intended to treat five major infection types - community-acquired pneumonia, hospital- and ventilator-acquired pneumonia, urinary tract infections, intra-abdominal infections, skin and soft tissue infections, for which non-inferiority pivotal studies are acceptable;
clinical development for medicines intended to treat acute otitis media, acute bacterial sinusitis, acute bacterial exacerbations of chronic bronchitis, inhalational antibacterial regimens in non-cystic fibrosis patients and for superficial skin infections, for which superiority studies could be required;
clinical development of medicines for which limited clinical data may be accepted because they address unmet clinical needs such as the potential to treat infections due to MDR organisms for which only few or no remaining therapeutic options are available;
clinical development of medicines for indications which could present problematic aspects, e.g. bacteraemia.
The new guidance also provide information on patient-selection criteria and primary endpoints, including efficacy variables and the timing of assessment outcomes. The additional details were included in respond to requests from the pharmaceutical industry and academia during the public consultation on the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections, and at a workshop held at the EMA in 2011.
EMA will be hosting a workshop on November 8, 2013 entitled Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem. The workshop will discuss regulatory options for approval of new antibacterials for human use and actions to increase appropriate use of antibiotics.