NETHERLANDS – The European Medicines Agency (EMA) has issued a final guideline for evaluating antibacterial medicines that is globally consistent with other regulators’ guidance.

The document, according to the EMA, addresses a “critical need for new antibacterial agents suitable for treating infections in patients with few remaining therapeutic options.”

The revised guidance was released following a public consultation in 2016 and reflects the outcomes of discussions between regulators in the EU, the US, and Japan to align their respective data requirements for antibacterial drugs in order to accelerate the development of such medicines globally.

The guidelines will go into effect on December 1, 2022. It supersedes an earlier 2012 guideline. Along with the guidance, the addendum on evaluating medicines to treat bacterial infections in children has been revised.

The updated recommendations for primary endpoints, primary analysis population, and non-inferiority margins in trials to support certain infection site-specific indications for use are included in the guidance.

The revision also clarifies clinical programs designed to meet an unmet need and includes new treatment guidelines for uncomplicated urinary tract infections and uncomplicated gonorrhea.

Antimicrobial resistance is a global threat that causes an estimated 33,000 deaths per year and costs €1.5 billion (US$1.6 billion) per year in healthcare costs and productivity losses.

A section on antibacterial pharmacokinetic and pharmacodynamic development is also removed because these topics are already covered in separate guidance.

The document applies to antibacterial agents that have been developed as single agents, antibacterial agents that have been developed for use in combination with one or more other specific antibacterial agents, and beta lactam (BL) agents that have been developed for use with beta-lactamase inhibitors (BLIs).

Some of the principles covered in the guide, according to the EMA, are also applicable to developing agents that affect bacterial virulence, bacteriophages proposed to treat infections, agents that indirectly inhibit bacterial growth and replication, and monoclonal antibodies used as a prophylaxis for specific indications.

The guidelines cover microbiological investigations as well as general clinical program considerations such as patient selection, clinical evidence of infection at enrollment, and microbiological evidence of infection at enrollment. It also covers sample collection and dosing regimens.

Other topics covered include when to transition patients from parenteral to oral therapy and how to compare antibacterial agents to licensed agents.

Children’s antibacterial development

In addition, the EMA issued an addendum addressing clinical development programs to support medicines used to treat bacterial infections in children.

The guidance, published on May 20, replaces a draft version published in April 2018.

EMA stated that “for the treatment of some infections, efficacy results can be extrapolated in certain age groups by looking at efficacy data from adults.”

The addendum mentions that companies developing new antibiotics need to develop an extrapolation concept and provide details about it in an extrapolation plan.

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