Boosting care for newborn babies in low-income countries

Press release 29/04/2016

Umbipro to help prevent umbilical cord infections

The European Medicines Agency (EMA) has recommended Umbipro (chlorhexidine digluconate), an antiseptic gel to prevent umbilical cord infections (omphalitis) in newborn babies, for use in countries outside the European Union (EU).

Chlorhexidine is an antibacterial agent, commonly used as a mouthwash and topical antiseptic. It works by killing or preventing the growth of bacteria on the skin. World Health Organization (WHO) treatment guidelines for newborn care recommend chlorhexidine for umbilical cord care for home births in regions with high neonatal mortality i.e. more than 30 deaths per 1,000 live births. It was identified by the United Nations as one of 13 life-saving commodities for women and children that if accessed more widely and properly used, could save the lives of more than six million women and children in the world's poorest countries.

Umbipro has been recommended for use to cleanse the umbilical cord stump of newborn babies to prevent serious infection, a major cause of newborn deaths in regions with high neonatal mortality. It was developed by the applicant in partnership with the UK-based charity Save the Children in response to a call from the United Nations' Commission on Life-Saving Commodities for Women and Children which is a part of the Every Woman, Every Child (EWEC) movement.

Umbipro was submitted to EMA under a regulatory procedure (Article 58) which allows the Agency to assess the quality, safety and efficacy of a medicine and give an opinion on its benefit-risk balance when used in low-income countries outside the EU. Article 58 products are assessed by EMA in collaboration with WHO and are required to meet the same standards as medicines intended for EU citizens.

The recommendation from EMA's Committee for Medicinal Products for Human Use (CHMP) is based on data from community-based trials with chlorhexidine in Nepal, Bangladesh and Pakistan. The studies showed a substantial reduction in mortality, ranging from 20% to 38%, in newborn infants who were delivered in community or primary care centres in resource-limited settings. The studies also showed a reduction in umbilical cord infection, ranging from 24% to 75%, when chlorhexidine was used.

The scientific opinion from the CHMP helps to support regulators in countries where regulatory capacity may be limited, by providing an expert evaluation of the medicine when used in local practice.

The CHMP reviewed Umbipro under EMA's accelerated assessment program. This is one of the Agency's main mechanisms to facilitate early access to medicines that fulfill unmet medical need.

The applicant received scientific advice from the CHMP. The scientific advice related to quality, non-clinical and clinical aspects of the dossier.

National regulators can use the CHMP's scientific assessment to decide on the use of the medicine in their jurisdictions.

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