European agency endorses antiseptic gel, developed through GSK and Save the Children partnership, for newborn umbilical cord infections in developing countries
29 April 2016
- Innovative reformulation of chlorhexidine in GSK mouthwash
- Chlorhexidine identified by UN as ‘life-saving commodity’ with potential to save 422,000 lives over five years1
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 today 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.1
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 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.
Notes to editors:
About Chlorhexidine digluconate gel:
• Chlorhexidine digluconate gel is currently not approved in any of the target markets (a review under Article 58 will not result in European licences following adoption of a CHMP opinion).
• 7.1% chlorhexidine digluconate gel (equivalent to 4% chlorhexidine) is intended exclusively for use against newborn umbilical cord infections in developing countries
• Research from three community-based randomised controlled trials in Nepal,2 Bangladesh3 and Pakistan4 showed that 4% aqueous chlorhexidine solution could prevent umbilical infections developing. These studies were published in the Lancet and were included to support the filing
• Further, a non-inferiority randomised controlled trial in Nepal showed a 7.1% chlorhexidine digluconate gel formulation was non-inferior to the aqueous solution in reducing bacterial colonisation of the umbilical cord stump5
• In January 2014, the WHO updated its guidelines on postnatal care of the mother and newborn and recommended the application of once-daily 7.1% chlorhexidine digluconate to the umbilical cord stump during the first week of life for newborns born at home in settings with high neonatal mortality rates (30 or more neonatal deaths per 1,000 live births)6
• 7.1% chlorhexidine digluconate is being added to the Essential Medicines List in many developing countries for neonatal care
• GSK is working with the Chlorhexidine Working Group (part of the newborn Technical Resource Team of the United Nations Commission on Life Saving Commodities for Women and Children) to support the global introduction and scale of 7.1% chlorhexidine for umbilical cord care
About GSK & Save the Children partnership:
• GSK and Save the Children launched a groundbreaking partnership in 2013. This collaboration combines their innovation, resources and expertise to help improve the health and prospects of some of the world’s most marginalised and vulnerable children. The partnership aims to help save one million children’s lives
• The partnership’s mission is in line with global objectives, including the new Sustainable Development Goals, to reduce preventable child deaths. In 2015, 5.9 million children under five died from preventable causes
• Developing the antiseptic chlorhexidine gel – and researching other child-friendly medicines – is one of a number of partnership initiatives. Other programmes include widening access to vaccination; training community health workers; responding to humanitarian crises; and advocating together for increased access to healthcare
• Since 2013, the partnership has reached more than 1.3 million children with lifesaving immunisations, treatments and other interventions
• The partnership has fully immunised more than 23,500 children under five; treated more than 125,000 children for malaria, diarrhoea and pneumonia; and trained more than 10,000 health workers to reach some of the most vulnerable and marginalised children and communities
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Save the Children
Save the Children works in more than 120 countries and helps to save children’s lives, fight for their rights and help them to fulfil their potential. For more information visit: www.savethechildren.org.uk.
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2015.
- United Nations. UN Commission on life-saving commodities for women and children. 2012 [URL last accessed April 2016: http://www.unicef.org/media/files/UN_Commission_Report_September_2012_Final.pdf]
- Mullany LC, et al. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet 2006;367(9514):910-918
- Arifeen Se, et al. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012;379(9820):1022-1028
- Soofi S et al. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Lancet. 2012;379(9820):1029-1036
- Hodgins S et al. Chlorhexidine gel versus aqueous for preventive use on umbilical stump. Pediatr Infect Dis J 2010;29:999-1003
- World Health Organization. WHO Recommendations on Postnatal Care of the Mother and Newborn. 2013. [URL last accessed 16 September 2015: http://apps.who.int/iris/bitstream/10665/97603/1/9789241506649_eng.pdf]