SAINT-PREX, SWITZERLAND--After nearly a decade of public-private collaboration, Ferring Pharmaceuticals today announces the first use of heat-stable carbetocin (Carbetocin Ferring) for the prevention of excessive bleeding after birth, known as postpartum haemorrhage (PPH). Heat-stable carbetocin is now available for use in healthcare facilities across India, in the prevention of excessive bleeding following vaginal and caesarean section births.

This major maternal health milestone has been eagerly awaited since the publication of the CHAMPION (Carbetocin HAeMorrhage PreventION) trial results in 2018[2] - a study led by the World Health Organization (WHO) as part of a collaboration with MSD for Mothers* and Ferring Pharmaceuticals. These data contributed to heat-stable carbetocin being added to the WHO Model List of Essential Medicines (EML),[3] as well as an update in the WHO’s recommendations on uterotonics for the prevention of excessive bleeding after birth.[4]

“Today is an unforgettable milestone for maternal health in India. Every 5 minutes a woman dies during pregnancy or childbirth across India and excessive bleeding after childbirth is responsible for 30% of these deaths,” said Dr Shivaprasad Goudar, Professor of Physiology, J N Medical College & Director-Research, KLE Academy of Higher Education and Research, Belagavi, India and Principal Investigator (India) for the CHAMPION clinical trial. “It is truly traumatic to see a mother die due to a preventable cause, and the impact this has on the family goes beyond the initial loss. Because this new formulation is not dependent on being stored or transported in refrigerators, it is a real step forward to ensuring women, especially in remote areas, can access high quality maternity care. The last few months have been an incredibly challenging time for India as we tackle the COVID-19 pandemic but it remains vital to prioritise maternal health to ensure the safety of expectant mothers at risk of excessive bleeding after childbirth.”

Until now, the first-choice drug for preventing excessive bleeding after birth required storage and transportation at 2-8°C, typically in a refrigerator to maintain its effectiveness. This is often difficult in low- and lower-middle income countries, many of which have hot climates and unpredictable power sources. As a result, many women are deprived of access to a lifesaving drug or the drug being less predictable and potentially being less effective because of exposure to heat. Carbetocin Ferring is a heat-stable formulation with predictable quality offering an additional option for healthcare professionals in preventing excessive bleeding after childbirth.

“At Ferring, we believe that every woman giving birth should have access to quality care and medicines to help them build families, regardless of where they live. Reaching the moment where the first woman receives heat-stable carbetocin is a landmark achievement for Ferring, which would not have been possible without collaboration, and we would like to thank all those involved, especially the patients in the clinical trial,” said Per Falk, President of Ferring Pharmaceuticals. “While we are hugely proud of achieving this milestone, our work will not stop here. Ferring is committed to supporting access to heat-stable carbetocin across the world in other low- and lower-middle income countries, so that we are closer to the vision that no woman dies giving life.”

Carbetocin Ferring was first approved in 2020, under the Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP), aimed to make essential medicines available faster for patients in low- and middle-income countries.[5,6] Since then, besides India, Carbetocin Ferring has been approved in South Sudan, Sierra Leone - the countries with the first and third highest rates of maternal mortality in the world respectively, and Tanzania.[7] Ferring and key partners are working to secure additional national registrations, to bring heat-stable carbetocin to the public sector of all low- and lower-middle income countries, where the burden of maternal mortality and cases of PPH are greatest.

Alongside it’s listing in the WHO Essential Medicines List, heat-stable carbetocin has been included in the UNFPA Product Catalogue for “quality-assured commodities related to reproductive health, census and humanitarian response”.[8,9]