European Medicines Agency Approves Antiseptic Gel To Prevent Newborn Infections

An antiseptic gel to avoid infections in the umbilical cord stump of newborns has earned the nod of the European Medicines Agency last week. The antiseptic gel is called Umbipro.

Umbipro, a three-year effort, was made by GlaxoSmithKline and charity organization Save the Children with developing countries in mind. The New York Times reported that there was a 2012 United Nations commission estimate of Umbipro potentially saving 85,000 babies annually. Meanwhile, The Guardian said that the United Nations estimated that the antiseptic gel would be able to save 422,000 babies over five years.

Fight to Prevent a Newborn Infection Receives a Lift. The new gel contains chlorhexidine https://t.co/91fiyaq4wn pic.twitter.com/8LrzUlVMIO

— Howard Farran DDS (@HowardFarran) May 3, 2016

Antiseptic Gel For Countries With High Newborn Mortality Rates

The endorsement by the European Medicines Agency allows GlaxoSmithKline to submit Umbipro to regulators in low-income countries where neonatal mortality rates are high, according to The Telegraph. If these regulators endorse the antiseptic gel, the company will then sell it for an affordable price. It will also engage in knowledge-sharing with local manufacturers with the goal of local production of the gel.

Many newborn deaths are caused by infections of the umbilical cord after it is cut. In Asia and sub-Saharan Africa, unclean materials like dung and ash are typically used on the newborn's umbilical cord.

Antiseptic Gel Was Based From Mouthwash

Umbipro was created by a team of scientists led by Pauline Williams. It was based from GlaxoSmithKline's Corsodyl mouthwash that contained chlorhexidine.

"Back in 2012 I had read some reports of two studies that were done in Pakistan and Bangladesh showing that chlorhexidine at a particular concentration dramatically reduced rates of severe infection and reduced neonatal deaths by a quarter," Williams said via The Telegraph. What followed a United Nations call for manufacturers to try making a product to avoid infection of the umbilical cord.

Williams said that since GlaxoSmithKline already had chlorhexidine in Corsodyl, she thought the company could respond to the call. "The gel had to contain a specific concentration of chlorhexidine and in a format that had enough stability so that it would last and would not degrade over a period of time in high heat and humidity," Williams said.

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