Business & Finance
Swissmedic Approves Carbetocin Ferring for the Prevention of Postpartum Haemorrhage in All Births
14 May 2020 - - Switzerland-based regulatory body Swissmedic has approved of Carbetocin Ferring, a heat-stable formulation of carbetocin, for the prevention of excessive bleeding after childbirth following all births, both vaginal and caesarean section, Switzerland-based Ferring Pharmaceuticals said.

Every year, 14 m women experience excessive bleeding after birth, also known as postpartum haemorrhage,2 which leads to approximately 70,000 deaths per year.

Although most deaths are preventable, PPH is the leading direct cause of maternal death worldwide,1 99% of which occur in low- and lower-middle income countries.

Carbetocin Ferring is the first medicine approved under the new Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP).

The MAGHP procedure builds on the existing Swissmedic procedure for Marketing Authorisation and makes it accessible to representatives of regulatory authorities in low- and middle-income countries.

The procedure's objective is to make essential medicines, like Carbetocin Ferring, available faster for patients in low- and middle-income countries.

This landmark approval in Switzerland paves the way as Ferring now seeks registrations for Carbetocin Ferring for the prevention of PPH following all births, in low- and lower-middle income countries, where the burden of maternal mortality is greatest.

Ferring is initially working with governments and partners in India, Kenya and Nigeria to secure the approval and introduction of Carbetocin Ferring, so that patients who need it can access it as soon as possible.

Carbetocin Ferring ampoules will be made available by Ferring at an affordable and sustainable price to publicly controlled or publicly funded healthcare facilities and healthcare facilities operating on a not-for-profit basis, including through social marketing, in low- and lower-middle income countries.

Ferring will supply Carbetocin Ferring from state-of-the-art manufacturing sites that have passed Good Practice Manufacturing inspections by stringent regulatory authorities.

Heat-stable carbetocin is included on the World Health Organization Model List of Essential Medicines, and in the WHO recommendations on uterotonics for the prevention of postpartum haemorrhage.

The EML identifies medicines essential for addressing the most important public health needs globally.

The guidelines recommend heat-stable carbetocin for the prevention of PPH in settings where oxytocin is unavailable or its quality cannot be guaranteed, and where its cost is comparable to other effective uterotonics.

CHAMPION (Carbetocin Haemorrhage Prevention), the largest clinical trial in the prevention of PPH, was a double-blind, randomised, non-inferiority trial designed to compare the effectiveness and safety of investigational heat-stable carbetocin to oxytocin in the prevention of PPH after vaginal birth.

The trial was funded by MSD for Mothers.

Heat-stable carbetocin is a long-acting uterotonic developed by Ferring Pharmaceuticals.

Ferring Pharmaceuticals is a research-driven, speciality biopharmaceutical group committed to helping people around the world build healthy families and live better lives.

Headquartered in Saint-Prex, Switzerland, Ferring is in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology.

Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth.

Founded in 1950, privately-owned Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Swissmedic, or The Swiss Agency for Therapeutic Products, is the Swiss surveillance authority for medicines and medical devices.