GlaxoSmithKline seeks EU approval for new chlorhexidine gel

GlaxoSmithKline is seeking European regulatory approval for its new chlorhexidine gel product for the prevention of umbilical cord infections in newborn babies.

A regulatory application has been submitted to the European Medicines Agency for its antiseptic chlorhexidine gel for the prevention of omphalitis in newborns, with the product having already been granted accelerated assessment status.

Work to develop the gel began in response to a call from the UN in 2012 for manufacturers to produce a high-quality chlorhexidine product suitable for newborn infants in low-resource settings.

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

Dr Pauline Williams, head of global health research and development at GlaxoSmithKline, said: "We are delighted to have reached this significant milestone, which brings us a step closer to help protect newborns from umbilical cord infection."

The gel is based on the antiseptic chlorhexidine solution used in Corsodyl mouthwash and has been optimised to be stable in regions of high heat and humidity with no cold chain storage.