GlaxoSmithKline (GSK), one of the world’s leading research-based pharmaceutical and healthcare companies, has submitted a regulatory application to the European Medicines Agency (EMA) for its antiseptic chlorhexidine gel (7.1 per cent chlorhexidine digluconate gel, equivalent to 4 per cent chlorhexidine) for the prevention of umbilical cord infections (omphalitis) in newborn babies.

GSK’s work to develop the gel began in response to a call from the United Nations (UN) in 2012 for manufacturers to make a high quality chlorhexidine product suitable for newborn infants in low resources settings.

The EMA has granted the application accelerated assessment, a process open to medicinal products of major public health interest and under which the EMA intends to provide a scientific opinion on the submission in a reduced timeframe of 150 days. The antiseptic gel is intended exclusively for use in developing countries and, if approved for use, GSK will offer it at a not-for-profit price and will share its manufacturing knowledge with others to enable it to be made locally.

Each year, approximately three million newborns die worldwide within the first 28 days of life, a quarter due to infection. A newly-cut umbilical cord acts as an entry point for the bacteria which can lead to newborn infection, sepsis and death. Umbilical cord infections are more likely to occur in low income settings; primarily in developing countries across Africa and South Asia where a high proportion of births take place at home. In 2012, a United Nations (UN) Commission Report identified chlorhexidine for newborn cord care as one of 13 overlooked ‘life-saving commodities’ that, if more widely accessed and properly used, could potentially save 422,000 neonatal lives over 5 years.

In response, GSK has worked to reformulate the antiseptic chlorhexidine solution used in GSK’s Corsodyl mouthwash into an antiseptic gel, using insights and on-the-ground knowledge from Save the Children, an international non-governmental organisation. The new gel formulation has been optimised to be stable in regions of high heat and high humidity with no cold chain storage and is presented in single-use sachets. This gel project is a major aspect of the GSK and Save the Children partnership, established in 2013, which aims to combine the resources and expertise of both organisations to help save the lives of a million children around the world.

Dr Pauline Williams, head of global health R&D in GSK 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 combination of GSK’s scientific, regulatory and manufacturing capabilities and Save the Children’s on-the-ground knowledge presented us with a unique opportunity to develop a medicine, by reformulating an existing product, to meet a priority need for newborns in developing countries.”

Simon Wright, head of Child Survival at Save the Children said, “The filing of chlorhexidine is an exciting step forward in our goal to help prevent newborn deaths. This formulation has been designed with some of the toughest settings in mind and, crucially, GSK is not looking to make a profit or even recoup their investment in research and development. Instead they want to offer this to other manufacturers to develop as a sustainable business.”

The GSK’s regulatory submission for its chlorhexidine gel will follow the Article 58 procedure, which allows the EMA to assess the quality, safety and efficacy of a medicine for a disease recognised by the World Health Organization (WHO) as a major public health interest, but intended exclusively for use outside of Europe. This assessment is undertaken by the EMA, in collaboration with the WHO, and requires applicants to meet the same standards as medicines or vaccines intended for use in the EU.

Data from three large published community-based randomised controlled trials of 4 per cent aqueous chlorhexidine solution in Nepal, Bangladesh and Pakistan have been included to support the filing. A meta-analysis of these studies indicated that chlorhexidine, versus dry cord care, soap and water or hand washing, delivered a 23 per cent reduction in all-cause newborn mortality. Further, a non-inferiority randomised controlled trial in Nepal showed a 7.1 per cent chlorhexidine digluconate gel formulation was non-inferior to the aqueous solution in reducing bacterial colonisation of the umbilical cord stump.

If a positive scientific opinion from the EMA is granted in 2016, GSK will request a Certificate of Pharmaceutical Product (CPP) which is an integral part of the marketing authorisation applications to National Regulatory Authorities (NRAs) in countries with regions of moderate-high neonatal mortality rates.

Since 2013, Save the Children has been a member of GSK’s Maternal and Neonatal Health R&D Advisory Board, helping GSK to shape its research activities and development of medicines for mothers and infants.