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Swissmedic Approves Carbetocin Ferring for the Prevention of Postpartum Haemorrhage in All Births

May 13, 2020 Off By BusinessWire

Excessive bleeding after birth, also known as postpartum haemorrhage (PPH), is the leading direct cause of maternal mortality worldwide,¹ causing approximately 70,000 deaths each year¹ – 99% of which occur in low- and lower-middle income countries²

Carbetocin Ferring is the first medicine approved under the new Swissmedic and Marketing Authorisation for Global Health Products (MAGHP) procedure,³ which aims to build capacity and speed up access to essential medicines in low- and middle-income countries⁴

Ferring developed this heat-stable formulation of carbetocin to specifically address limitations in refrigeration and cold-chain transport of PPH medications in low- and lower-middle income countries⁵

Heat-stable carbetocin is recommended for PPH prevention in settings where oxytocin is unavailable or its quality cannot be guaranteed, and where its cost is comparable to other effective uterotonics⁶

SAINT-PREX, Switzerland–(BUSINESS WIRE)–Ferring Pharmaceuticals today welcomes the Swissmedic approval 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.⁵

Every year, 14 million women experience excessive bleeding after birth, also known as postpartum haemorrhage (PPH),² which leads to approximately 70,000 deaths per year.¹ 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.²

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.⁴

“As the COVID-19 pandemic impacts healthcare systems, communities and families all over the world, protecting maternal health has never been so critical. This milestone approval marks the first step towards ensuring that this innovative medicine reaches the women who need it – and reducing the thousands of preventable deaths from PPH every year, said Per Falk, President and Chief Science Officer at Ferring Pharmaceuticals. It is thanks to the collaboration with the World Health Organization and MSD for Mothers that we can mark this milestone and work towards development goals in global health.”

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.² 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.

“This regulatory milestone is testament to the potential that public-private partnerships hold to address public health challenges, said Dr Julie L. Gerberding, Chief Patient Officer at MSD. Our ultimate goal through MSD for Mothers is to help create a world where no woman has to die while giving life. Today’s announcement brings us one step closer to realising this vision by improving the response to prevent PPH.”

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.⁷

“The loss of any woman during childbirth is a tragedy. Yet so many of the deaths caused by postpartum haemorrhage can be prevented, said Dr. Yeshita V Pujar, Consultant gynaecologist-obstetrician, KLES Prabhakar Kore Hospital & Medical Research Centre, Karnataka, India. This heat-stable formulation of carbetocin will play an important role in PPH prevention in countries which carry the greatest burden of maternal mortality, especially low- and lower-middle income countries. Many of these are in hotter parts of the world where cold-chain storage remains difficult to achieve and maintain. A heat-stable alternative for the prevention of PPH will be critical in saving maternal lives in settings where other effective uterotonics are unavailable or their quality cannot be guaranteed.”

Heat-stable carbetocin is included on the World Health Organization (WHO) Model List of Essential Medicines (EML),⁸ 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.⁷ 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.**⁶

About the CHAMPION trial⁹CHAMPION (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.

* This price is a subsidised price of $0.31 +/- 10% per ampoule of 100 µg Carbetocin Ferring, Ex Works. This is comparable to the current United Nations Population Fund price for oxytocin of $0.32 per unit (10 I.U.).¹⁰** The availability of Carbetocin Ferring is subject to regulatory review and approval in relevant countries.

*** Accurate as of trial closure in 2018

**** MSD for Mothers is an initiative of Merck & Co., Inc., Kenilworth, N.J., U.S.A.

About 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 a leader 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.

Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

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References

¹ Say L, et al. Global causes of maternal death: a WHO systematic analysis. Lancet Global Health. 2014; 2(6):e323-e333. Available at: https://www.thelancet.com/pdfs/journals/langlo/PIIS2214-109X(14)70227-X.pdf Last accessed: May 2020

² WHO. Priority diseases and reasons for inclusion. Postpartum haemorrhage. Available at: http://www.who.int/medicines/areas/priority_medicines/Ch6_16PPH.pdf Last accessed: May 2020

³ Swissmedic. First MAGHP approval in Switzerland. Available at: https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/authorisations/informationen/first-maghp-approval-inswitzerland.html Last accessed: May 2020

⁴ Swissmedic. Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP). Available at: https://www.swissmedic.ch/swissmedic/en/home/about-us/development-cooperation/marketing-authorisation-for-global-health-products.html Last accessed: May 2020

⁵ World Bank. World Bank Country and Lending Groups. Published 2019. Available at: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups Last accessed: May 2020

⁶ WHO. WHO recommendations: Uterotonics for the prevention of postpartum haemorrhage. Available at: https://apps.who.int/iris/bitstream/handle/10665/277276/9789241550420-eng.pdf?ua=1 Last accessed: May 2020

⁷ Data on file

⁸ WHO Model List of Essential Medicines. Available at: https://apps.who.int/iris/handle/10665/325771 Last accessed: May 2020

⁹ Widmer M, et al. Heat stable carbetocin vs oxytocin to prevent hemorrhage after vaginal birth. New England Journal of Medicine 2018;379:743-752

¹⁰ UNFPA Procurement Services. Oxytocin 10 I.U./ml injection in 1ml ampoule. www.unfpaprocurement.org/products?id=OXYTOCIN_10IU/ML Last accessed: May 2020