By Arielle Garton
We’ve been working with GSK to reformulate an antiseptic gel from a popular mouthwash – and today it’s been approved by the European Medicine Agency. It’s a decision that could soon contribute to saving hundreds of thousands of children’s lives in communities most in need.
The chlorhexidine gel, that prevents umbilical cord infections (omphalitis) in newborns, was developed as part of our groundbreaking partnership with GSK.
We’ve been in partnership with GSK since 2013, combining our expertise and experience of reaching the world’s most marginalised and vulnerable children with their research and development know-how. Together, we aim to help save one million children’s lives. It’s an ambitious goal, and today’s an important milestone.
“A life-saving commodity”
The cutting of the umbilical cord is one of the moments during birth when children are at risk of infection. Bacteria can enter their body and the chance of infection is dangerously high.
Across Sub-Saharan Africa and Asia where many births take place at home in unsterilised conditions, the dangers are even greater. And the impact can be deadly.
Every year approximately three million babies die within their first 28 days of life. A startling one quarter of these deaths are due to infection, most often from the newly cut umbilical cord. But they can be so easily prevented.
In 2012, a United Nations (UN) Commission Report had recognised chlorhexidine was an overlooked “life-saving commodity” that, if more widely accessed and properly used, could potentially save 422,000 neonatal lives over five years.
It was when GSK’s scientists recognised that an ingredient in the company’s Corsodyl™ mouthwash could be transformed into a medicine that real progress started to occur.
Since then, we’ve been working with GSK to help them develop a product that works for the remote communities that often need the medicine most. The result is a heat stable gel, available in single use sachets – designed for communities in hot and humid environments, where refrigeration is hard to come by.
What happens now?
The positive scientific opinion offered by the European Medicines Agency’s Committee for Medicinal Products for Human Use is a big step towards the medicine becoming widely available in the countries where it’s needed most.
Next, GSK will submit local regulatory applications for the gel in low-income countries with moderate to high rates of neonatal deaths where supply is needed. Once it’s been registered, GSK will offer the gel – that will be distributed under the trade name Umbipro™ – at a not-for-profit price.
GSK plans to initially manufacture around six million sachets, but this could increase depending on global demand. They’ve also said they’ll share their manufacturing knowledge with other interested companies to enable them to make the gel.
Ali Forder, our Director of Programme, Policy and Quality describes today’s decision as “an exciting step forward in our efforts to help prevent newborn deaths from infections,” adding that Save the Children will, “continue to work closely with governments to ensure children have access to quality healthcare and essential medicines.” Today’s an important step towards that goal.