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Enabling an Accelerated Development Path for Chlorhexidine Digluconate Gel 7.1% w/w for the Prevention of Omphalitis

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      In 2012, the United Nations (UN), identified chlorhexidine as a Life-saving Commodity and called for the development of a chlorhexidine product suitable for the prevention of omphalitis (umbilical cord infection) in developing countries. In response, GlaxoSmithKline (GSK) set out to develop a chlorhexidine digluconate 7.1% w/w gel, in partnership with Save the Children. The vision was to develop a gel which could pass a stringent regulatory review thereby assuring a safe, effective, and quality product. Review under the European Medicines Agency’s (EMA) Article 58 pathway was pursued, with accelerated assessment granted. The regulatory dossier compiled literature-based evidence for clinical efficacy and safety, supplemented by GSK-generated in-vitro studies and a full CMC data package to support the quality. No new clinical trial data or in vivo non-clinical study data were submitted. A positive opinion from the EMA was received in 2016. The time from the initial UN call to EMA Positive Opinion was 3 years and 7 months.

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      GlaxoSmithKline R&D Ltd, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK
      Author notes
      *Corresponding author. Tel.: +44 7818 527850 E-mail: elena.deangelis@
      British Journal of Pharmacy
      University of Huddersfield Press
      11 July 2018
      : 2
      : 2 , Proceedings of the 8 th APS International PharmSci 2017
      : S45-S46
      © 2017, L. Immins, N. Jibry, D. Hunt, K. Cheng, P. Chowdhury, C. Patel, S. Wilhelm, E. DeAngelis, P. Williams

      This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY) 4.0



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