hdr isap 2019

News November 2013

The European Medicines Agency (EMA) recently released an Addendum to the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections. One of the most important aspects of the addendum is that it outlines a new approach facilitating the development of antibacterial agents targeted against multidrug-resistant pathogens where patients have very limited or no remaining treatment options. Accepting limited evidence of clinical safety and efficacy is strongly based on extensive preclinical and clinical PK/PD analyses. PK/PD studies may play a pivotal role in alternative study designs in indications where placebo controls are required as well as in limited pre-licensure clinical development programmes targeting multidrug-resistant pathogens.The field of PK/PD will be an essential pilar in the development of novel antibacterial drugs to treat infections due to multidrugresistant organisms that are currently uncommon or rare and for which there are few remaining therapeutic options.