EMA releases final guideline on antibacterial drug development

Regulatory NewsRegulatory News | 24 May 2022 |  By 

The European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that is globally aligned with guidance from other regulators.
EMA said the document addresses a “pressing need for new antibacterial agents suitable for treating infections in patients with few remaining therapeutic options.”
The agency announced that antimicrobial resistance poses a “global threat” and is responsible for an estimated 33,000 deaths per year with a cost of €1.5 billion per year in healthcare costs and productivity losses.
The publication of the revised guidance follows a public consultation held 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 to expedite the development of such medicines worldwide.
The guidance will come into effect on 1 December 2022. It replaces an earlier guideline from 2012. The addendum on evaluating medicines to treat bacterial infections in children has been revised alongside the guidance. (RELATED: EMA Consults on Harmonized Antibacterial Drug Development Guideline, Regulatory Focus 14 January 2019).
The guidance contains revised recommendations for primary endpoints, primary analysis population and non-inferiority margins in trials to support certain infection site-specific indications for use. The revision also provides clarifications on clinical programs that are intended to address an unmet need and includes new guidance to treat uncomplicated urinary tract infections and uncomplicated gonorrhea.
The update also removes a section on antibacterial pharmacokinetic and pharmacodynamic development because these topics are already addressed in separate guidance.
The document applies to antibacterial agents developed as single agents, antibacterial agents developed for use in combination with one or more other specific antibacterial agents and beta lactam (BL) agents developed for use with beta-lactamase inhibitors (BLIs).
EMA said some of the principles covered in the guide are also applicable to developing agents that affect bacterial virulence, bacteriophages proposed to treat infections, agents that inhibit bacterial growth and replicate indirectly and monoclonal antibodies used as a prophylaxis for specific indications.
The guidance addresses microbiological investigations; general considerations for clinical programs, such as patient selection, clinical evidence of infection at enrollment and microbiological evidence of infection at enrollment. It also addresses specimen collection and dosing regimens.
Other topics include when to switch patients from parenteral to oral therapy and how to test antibacterial agents with licensed agents.
Addendum address antibacterial development children
EMA also issued an addendum addressing clinical development programs to support medicines to treat bacterial infections in children. The guidance, issued on 20 May, replaces a draft version issued in April 2018.
EMA announced 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 deials about it in an extrapolation plan.”
EMA guideline on antimicrobials
EMA addendum on pediatric antibacterial development


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