GSK, one of the world’s leading research-based pharmaceutical and healthcare companies, has submitted an application to the European Medicines Agency (EMA) for its antiseptic chlorhexidine gel to be used in prevention of umbilical cord infections in newborn babies, especially in developing countries such as Malawi.
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, according to a statement made available to The Nation.
Further, the firm said 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.
“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 time frame of 150 days,” reads part of the statement.
In 2012, a United Nations (UN) Commission Report identified chlorhexidine for newborn cord care as one of the 13 overlooked “life-saving commodities” that, if more widely accessed and properly used, could potentially save 422 000 neonatal lives over five years.
Head of Global Health Research and Development in GSK, Pauline Williams, expressed delight that GSK have reached the significant milestone which brings it a step closer to help protect newborns from umbilical cord infection.