EMA, FDA and PMDA aim to give antibiotic firms option of global trial programme

Last week​ the regulators said they had agreed to align their data requirements​ “for certain aspects of the clinical development of new antibiotics in order to stimulate the development of new treatments to fight antimicrobial resistance and protect global public health​.”

A European Medicines Agency (EMA) spokeswoman told us the aim is to allow drug companies to conduct “a single development programme that can address the data requirements of the three regulators​.”

The regulators discussed antibiotics for the treatment of intra-abdominal and skin infections as well as diseases of the respiratory and urinary tracts.

For urinary tract infections the agencies agreed on the primary endpoint to be used in trials with regard to the assessment of the clinical and microbiological response.

Similarly, for antibiotics for the treatment of intra-abdominal infections the regulators decided on the maximum number of patients with appendicitis that can be included in trials.

Treatments for resistant infections​

The agencies also reached agreement on aspects of clinical trials for antibiotics being developed to treat resistant micro-organisms.

The EMA spokeswoman told us: “Regarding multi-drug resistant (MDR) bacteria, it was acknowledged by the three regulators that it is difficult to conduct randomised clinical studies with patients harbouring infections caused by MDR pathogens for which few therapeutic options are available.​

“Moreover, since these studies would inevitably be small in size and recruit heterogeneous patient populations, the interpretation of the data is expected to be challenging​” she continued.

To address this, the agencies started discussed ways drug candidates in the treatment of non-resistant organisms and supplement this data with a microbiological assessment of pharmacokinetic and pharmacodynamic data in multi-drug resistant bacteria.

The EMA spokeswoman said: “The approaches towards streamlined clinical development in areas of unmet medical need will be further discussed in future meetings​.”