GSK submits regulatory application for chlorhexidine gel to prevent newborn infections

GSK plc announced on October 12, 2015, that it has submitted a regulatory application to the European Medicines Agency (EMA) for its antiseptic chlorhexidine gel. The gel is designed for the prevention of umbilical cord infections (omphalitis) in newborn babies, particularly in low-resource settings.

The application follows a 2012 call from the United Nations (UN) for manufacturers to develop a high-quality chlorhexidine product suitable for newborns in developing countries. The EMA has granted the application accelerated assessment due to its potential public health significance. The product is intended exclusively for use in developing countries, and if approved, GSK plans to offer it at a not-for-profit price and share manufacturing knowledge to enable local production.

Neonatal infections remain a significant cause of death, with approximately three million newborns dying within the first 28 days of life globally each year, largely due to infections. The umbilical cord is a common entry point for bacteria. To address this, GSK reformulated its chlorhexidine solution, previously used in mouthwash, into a gel. This formulation is optimized for stability in hot and humid climates without requiring cold chain storage and is provided in single-use sachets.

This gel development is a key aspect of GSK's partnership with Save the Children, established in 2013. The collaboration aims to combine expertise and resources to help save the lives of children in developing countries. If the EMA grants a positive scientific opinion in 2016, GSK will seek a Certificate of Pharmaceutical Product (CPP) to support marketing authorization applications in countries with high neonatal mortality rates.

Data from three large community-based randomized controlled trials supported the application, showing that chlorhexidine reduced all-cause neonatal mortality by 23% compared to basic cord care. A trial on the specific 7.1% gel formulation also demonstrated its non-inferiority to the aqueous solution in preventing bacterial colonization of the umbilical cord stump.