Updates from EMA, FDA, and UK NICE at the 6-8 Sep 2017 ASM-ESCMID Antibiotic Development Conference

Dear All:

On Wednesday 6 Sep at the ASM-ESCMID Conference on Antibacterial Development, we heard 3 superb back-to-back talks on the evolving regulatory and health technology assessment (HTA) landscape.

The speakers (Marco Cavaleri, PhD, Head of Anti-Infectives and Vaccines, EMA; Sumati Nambiar, MD, Director, Division of Anti-infective Products, FDA; and Colm Leonard, MD, Consultant Clinical Adviser, National Institute for Health and Care Excellence) have kindly agreed to make their presentations available and you can download them here as a 1.5MB .zip file. You’ll want to review the talks yourself, but let me point out these highlights:

  • First and foremost, it is only in the setting of products with a clearly articulated ability to address Unmet Need that (a) the increased risk associated with a smaller program can be justified and (b) a value argument can be articulated on the basis of a small program. This is a critical theme that came through over and over.
  • There is a steady movement by EMA, FDA, and PMDA towards tripartite (Japan, US, EU) harmonization. Not everything can be harmonized, but where possible it is being done. As an example, the CFU/ml cut-off for measuring response in cUTI has been harmonized. This may sound like a small thing, but it has real practical implications for those running clinical trials.
  • EMA will update their antibacterial guidance during 2018. This update will capture things like the newly harmonized cUTI measure just mentioned. I’d also predict updates that move in directions foreshadowed both in the July 2016 EMA PK-PD guidance as well as FDA’s Aug 2017 Unmet Need Guidance. It is great to see the steady evolution in thinking!
  • Approaches to approvals for use in pediatrics likewise continue to evolve. Increasingly, there is recognition that generating age-based PK data is often (not always, but often) all that is needed for antibiotics.
  • FDA will begin to move all breakpoint data from the product label to a website that can be updated as needed much more easily.
  • UK NICE has over the past year become deeply and thoughtfully engaged in evaluating pragmatic approaches to antibiotic HTA that will work with the updated regulatory strategies. The core message here is that antibiotic HTA needs to go beyond focusing solely on the immediate costs of care to consider costs of resistance, societal benefit, and also to model future resistance and usage. These messages parallel those released at the final DRIVE-AB conference.

MANY thanks to our colleagues at these agencies both for being so available to the community and for their steady, multi-year efforts to find a pragmatic path forward that balances Unmet Need with risk. We are truly having conversations now that were not possible even 5 years ago!

Best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Chief Strategy Officer, CARB-X | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog/

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