GSK, Save The Children partnership receive positive scientific opinion from CHMP for chlorhexidine

An antiseptic chlorhexidine gel to prevent umbilical cord infections (omphalitis) in newborn infants in developing countries, advanced through GSK and Save the Children’s groundbreaking partnership, has recently been granted a positive scientific opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This marks a major milestone for the partnership and its mission to help save the lives of children in the world’s poorest communities.

Infection is a major cause of newborn mortality, which can be caused by bacteria entering the body through a newly-cut umbilical cord. This is more likely to happen in low-income settings across sub-Saharan Africa and Asia where more births take place at home and unsterile materials, such as dung and ash, may traditionally be used on the umbilical cord stump. In 2012, a United Nations (UN) Commission Report named chlorhexidine for newborn cord care as an overlooked ‘life-saving commodity’ that, if more widely accessed and properly used, could potentially save 422,000 neonatal lives over five years.

In response, GSK worked to reformulate the antiseptic solution used in its Corsodyl™ mouthwash into a gel (chlorhexidine digluconate gel 7.1%, equivalent to 4% chlorhexidine), incorporating Save the Children’s expertise in reaching some of the most vulnerable and marginalised children. Insights and guidance from Save the Children informed key decisions in the development programme. A gel formulation was selected and developed to be stable in high heat and humidity, avoiding the need for refrigeration, to simplify distribution to remote communities. The gel is packaged in individual single-use foil sachets which can be opened without scissors. Pictorial instructions on the sachet and packaging are provided to help mothers who may not be able to read to apply the gel appropriately.

GSK will next submit local regulatory applications for the gel in low-income countries with moderate to high rates of neonatal deaths where supply is needed. If approved, GSK will offer the gel – to be distributed under the trade name Umbipro™ – at a not-for-profit price. GSK plans to initially manufacture around six million sachets, increasing capacity according to global demand, and will share its manufacturing knowledge with other interested companies to enable them to make the gel.

Commenting on today’s milestone, Patrick Vallance, president, pharmaceuticals R&D, GSK, said “A bright idea from one of our scientists who recognised we could transform an ingredient in our mouthwash into a medicine – has come to fruition thanks to the power of partnership. By combining our development and manufacturing expertise, in both pharmaceuticals and consumer health, with Save the Children’s on-the-ground knowledge of local healthcare systems and communities, we have developed a simple gel to help protect vulnerable newborns from infection. This is a real illustration of how collaboration can stimulate imaginative responses to tough challenges.”

Ali Forder, Director of Programme, Policy and Quality, Save the Children, commented: “The positive opinion for this reformulation of chlorhexidine is an exciting step forward in our efforts to help prevent newborn deaths from infections. This formulation has been designed with some of the toughest settings in mind and our expertise of working with health workers and communities has meant that this product can be used in challenging contexts. Our innovative partnership with GSK goes beyond the traditional corporate-charity model and this is a good example of how together we can achieve better outcomes for children. Save the Children will continue to work closely with governments to ensure children have access to quality healthcare and essential medicines.”

The gel was reviewed under the EMA’s Article 58 procedure and granted accelerated assessment. This procedure allows the EMA to conduct a scientific assessment and provide opinions, in co-operation with the World Health Organization (WHO), on medicines for human use that are intended exclusively for markets outside the European Union (EU), for diseases recognised by the WHO as of major public health interest.