GlaxoSmithKline (GSK) has submitted a regulatory application to the European Medicines Agency (EMA) seeking approval for its antiseptic chlorhexidine gel to prevent umbilical cord infections (omphalitis) in newborn babies.

Development of the chlorhexidine gel (7.1% chlorhexidine digluconate gel, equivalent to 4% chlorhexidine) started in 2012, following a call from the United Nations (UN) to develop a high-quality chlorhexidine product suitable for newborn infants in low resources settings.

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An accelerated assessment has been granted by the EMA for the application, with the regulator intending to provide a scientific opinion on the submission in a reduced time frame of 150 days.

The antiseptic gel is intended for use in developing countries and if approved for use, the company will offer it at a not-for-profit price and will share its manufacturing knowledge with others to enable it to be made locally.

"This formulation has been designed with some of the toughest settings in mind."

The application was supported by data obtained from three large published community-based randomised controlled trials of 4% aqueous chlorhexidine solution in Nepal, Bangladesh, and Pakistan.

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A meta-analysis of these studies indicated that chlorhexidine, when used against dry cord care, soap and water or hand washing, delivered a 23% reduction in all-cause newborn mortality.

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In addition, a non-inferiority randomised controlled trial undertaken in Nepal showed that a 7.1% chlorhexidine digluconate gel formulation was non-inferior to the aqueous solution in reducing bacterial colonisation of the umbilical cord stump.

The antiseptic gel is a reformulated version of the antiseptic chlorhexidine solution used in the company’s Corsodyl mouthwash, and was developed in response to a call to develop chlorhexidine products suitable to save the lives of newborn babies in developing countries.

Presented in single-use sachets, the new gel formulation leverages sights and on-the-ground knowledge from Save the Children, and has been optimised to be stable in regions of high heat and humidity with no cold chain storage.

Save the Children child survival head Simon Wright said: "This formulation has been designed with some of the toughest settings in mind and, crucially, GSK is not looking to make a profit or even recoup their investment in research and development."

The company intends to receive a positive scientific opinion from the EMA in 2016 and then request a certificate of pharmaceutical product (CPP), which is an integral part of the marketing authorisation applications to the national regulatory authorities (NRAs) in countries with regions of moderate-high neonatal mortality rates.