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news.The European Medicines Agency (EMA) has received an application from GlaxoSmithKline (GSK) seeking approval of its antiseptic chlorhexidine gel for the prevention of umbilical cord infections in newborn babies.
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The regulator has granted the filing accelerated assessment, under which it intends to provide a scientific opinion on the submission in a reduced time frame of 150 days.
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.
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.
Additionally, a non-inferiority randomised controlled trial undertaken in Nepal demonstrated 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 GSK’s Corsodyl mouthwash, and was developed in response to a call from the UN in 2012 for chlorhexidine products suitable to save the lives of new born 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 high 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."
GSK hopes to receive a positive scientific opinion from the EMA in 2016, and then request a certificate of pharmaceutical product, which is an integral part of the marketing authorisation applications to the national regulatory authorities in countries with regions of moderate-high neonatal mortality rates.
Approximately three million newborns die worldwide within the first 28 days of life each year, a quarter due to umbilical cord infections, which are especially higher in developing countries across Africa and South Asia.