Final CABP and HABP-VABP guidances from FDA; EU seeks to accelerate access to medicines

Dear All, Some regulatory updates today.

From FDA, we have final versions of their CABP and HABP-VABP guidance documents. My initial review suggests no big changes:

  1. CABP (Community-Acquired Bacterial Pneumonia)
    • The draft from Jan 2014 has been updated with a final version dated June 2020 (link).
    • I generated a comparison between the two (link).
    • The prior antibiotic exclusion (up to 25% with a single prior dose of a short-acting antibacterial) is unchanged.
    • The symptom-based primary endpoint is unchanged but the timing for same is now fixed at Day 4.
      • As before, a 28-day all-cause mortality endpoint is also offered but feasibility concerns are raised.
    • The NI margin is unchanged (12.5%).
    • There is some tightening around the PORT score requirements (if the drug is IV, all patients must be PORT III or higher).
  2. HABP-VABP
    • The draft from May 2014 has been updated with a final version dated June 2020 (link)
    • I generated a comparison between the two (link).
    • The prior antibiotic exclusion (more than 24h of a potentially effective drug in the prior 72h) is unchanged.
    • A primary endpoint of all-cause mortality at a fixed time in the window 14-28 days after enrollment is still suggested as the best choice
      • As before, a second choice of survival with no disease-related complications is also offered. 
    • The NI margin is unchanged at 10%.

 

From EU, there is a new strategy to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. It will address:

  • the life cycle of medicines from R&D to authorisation and patient access
  • how to put scientific and technological advances into practice
  • how to fill market gaps (e.g., new antimicrobials)
  • lessons learnt from COVID-19 on how to better prepare for future pandemics.

The details directly from the EU Commission are here. This article (link) from Reuters was a good read as well.

Antimicrobials are specifically mentioned in the 4-page roadmap and I found this to be encouraging: “The strategy will also seek to address market failures (e.g. lack of new antimicrobials) and build on initiatives to support the financial and fiscal sustainability of health systems. It is linked to the Commission’s industrial strategy and will create synergies with other policies and key Commission priorities (e.g. the EU Green Deal, Europe’s beating cancer plan, research and innovation, competition, intellectual property rights).” It’s great to see the market failure problem noted directly by the EU … I look forward to action beyond the exemplary leadership from the UK (link).

 

As always, many thanks to our colleagues in government for carrying on with these important updates and initiatives!

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

Current funding opportunities:

  • Novo REPAIR Impact Fund is open for global applications through 21 Jul 2020. Go here for current details.
  • 2020 funding rounds for CARB-X have not been announced.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes funders and projects by geography, stage, and more.


Upcoming meetings of interest to the AMR community:

  • 30 Jun 2020 (online, 17:00-18:30 CEST): GARDP REVIVE webinar. Title: “Clinical development of antimicrobials – Phase 1 development challenges.” Speaker: Markus Zeitlinger. Go here to register.
  • 9 Jul 2020 (online, 09:00-10:30 CEST): GARDP REVIVE webinar. Title: “The challenges and opportunities for antimicrobial R&D in low- and middle-income countries – India case study.” Speaker: Anand Anandkumar and Kamini Walla. Go here to register.
  • 17 Jul-2 Aug 2020 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
  • 27 Jul-31 Jul 2020 (online): Small World Initiative Instructor Training Workshop – training for undergraduate professors and high school teachers in wet lab techniques, parallel curricula, & pedagogical instruction to engage students in the hunt to find new antibiotics in soil (also covering distancing learning options). Go here to register.
  • 4 Aug 2020 (Silver Spring): FDA workshop entitled “Development Considerations of Antifungal Drugs to Address Unmet Medical Need.” Go here to register.
  • 5 Aug 2020 (Silver Spring): FDA workshop entitled “Developing Antifungal Drugs for the Treatment of Coccidioidomycosis (Valley Fever) Infection.” Go here to register.
  • September 2020. University of Sheffield (UK). Applications are being taken for a new 1-year (full-time) or 2-year (part-time) Masters of Science course in Antimicrobial Resistance. The program runs annually from September and covers microbiology, clinical practice and policy. The course webpage is here.
  • 9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
  • 26-29 Oct 2020 (online meeting), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)
  • 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
  • 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
  • 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
  • 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students.
  • 18-21 May 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.

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