EMA Issues Draft Antibiotics Guideline

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 09-29-2015 15:30


The European Medicines Agency (EMA) has released a draft guideline for public consultation on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics. The document provides guidance for the conduct of analyses to facilitate and speed up the development of new antibiotics, in particular those targeting multi-drug resistant bacteria. Comments on this draft guideline are due by March 31, 2016.

The EMA releases the draft guideline to address a public health issue of the increasing emergence of bacteria that have become resistant to a wide range of antibiotics. On the one hand it is essential to encourage the prudent use of antibiotics so that development of antimicrobial resistance can be reduced to a minimum, on the other hand new antibiotics are urgently needed for the treatment of serious infectious diseases, in particular when patients have very limited or no remaining treatment options. A central pillar in EMA’s strategy to fight antimicrobial resistance is to offer an environment that stimulates and facilitates development of innovative antibiotics.

With the development of modelling and simulation methods, pharmacokinetics and pharmacodynamics analyses, which are conducted prior to the start of clinical trials in humans and throughout the clinical development, play an increasing role during the development of a new antibiotic by providing evidence around the appropriateness of the dose and frequency of administration that should be used in patients to achieve the optimal benefit-risk balance. If they are conducted in a robust manner, these analyses have the potential to reduce the size of the clinical development program, according to the EMA. These analyses are particularly crucial in the development of new antibiotics that address unmet medical needs or target multi-drug resistant bacteria since they contribute to streamlining and accelerating the development using innovative data-gathering strategies, in line with the new regulatory approach described in the EMA addendum to the guideline on the evaluation of medicines for the treatment of bacterial infections. They also provide important data to inform the selection of dose regimens that may minimize the risk of developing resistant bacteria.

The draft guideline reflects both the recent scientific advances and the regulatory experience in this area. It provides guidance to medicine developers for the conduct of pharmacokinetics and pharmacodynamics analyses and outlines the regulatory requirements regarding the type of data that need to be collected, their analyses and interpretation, in view of a marketing authorisation application.

The EMA is organizing a workshop on November 12-13, 2015 with a broad range of stakeholders, including academia, regulatory agencies, industry as well as international and EU experts in the field, to discuss the draft guideline. The discussions will inform the finalization of the document. Attendance at the workshop is by invitation only. However, the workshop will be broadcast live on the EMA website.

Source: European Medicines Agency


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