SAINT-PREX, Switzerland--(BUSINESS WIRE)--Ferring Pharmaceuticals today announced that Propess® (dinoprostone) has been approved by the Minister of Health, Labour and Welfare (MHLW) in Japan for initiation of cervical ripening in patients at term (from 37 completed weeks of gestation).1 This is the first time in over 20 years that a pharmacological therapy for cervical ripening has been approved in the country.2
Around 10 per cent of births globally require induction of labour, which may be required if the health of the mother or baby is at risk.3,4 Cervical ripening is carried out prior to induction to prepare the cervix for birth. This approval offers women requiring an induction in Japan greater choice of alternatives to mechanical methods of cervical ripening.
“The approval of Propess in Japan is a big step forward in offering women more choice when it comes to cervical ripening,” said Per Falk, President and Chief Science Officer, Ferring Pharmaceuticals. “There is a lack of research and development of treatment options for women who are pregnant or giving birth, which is why it is important for Ferring to continue to invest and advance the field of Reproductive Medicine and Maternal Health and continue with our purpose of building families worldwide.”
The announcement today follows a close collaboration between Ferring Pharmaceuticals and a local patient advocacy group to ensure the needs and safety of women in labour are addressed in Japan.
“For women giving birth, mechanical methods may not always be the right option and it is important that a woman’s safety and comfort is paramount,” said Mikiya Kitamura, Vice President, Ferring Japan R&D. “Ensuring that a treatment is safe and effective is a priority for us, and we are pleased to have been able to work together with our local patient advocacy group on this significant milestone.”
Propess is currently marketed in over 60 countries and was developed in the 1980s in Scotland where it continues to be manufactured. As leaders in Reproductive Medicine and Maternal Health, this approval demonstrates Ferring’s continued commitment to helping people around the world to build healthy families.
Propess is a vaginal delivery system containing the active substance dinoprostone 10 mg used for the initiation of cervical ripening in women at term (from 37 completed weeks of gestation). The dinoprostone softens and opens the part of the birth canal known as the cervix, to start the process of labour.
Labour is initiated or induced by obstetricians in situations where it is considered safer, for the mother or the unborn child, to be delivered. This could be due to pre-eclampsia (sudden, severe rise in blood pressure and kidney impairment), poor growth in the baby, unexplained bleeding in the last phase of pregnancy or a prolonged pregnancy (the most common reason). The success of induction of labour is related to the condition of the cervix prior to the induction. If during examination of the cervix length, positioning and softening, it is deemed unfavourable, then cervical ripening will be initiated.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty 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.
1 Minister of Health, Labour and Welfare (MHLW). Approval of Propess (dinoprostone). January 2020. Japan New Drug Application (NDA) approval document.
2 Ferring Pharmaceuticals. Data on file. January 2020.
3 World Health Organization. WHO Recommendations for Induction of Labour. Geneva: World Health Organization; 2011. Available at: https://www.who.int/reproductivehealth/publications/maternal_perinatal_health/9789241501156/en/ Last accessed: January 2020.
4 The American College of Obstetricians and Gynecologists. Frequently asked questions: Labor delivery and postpartum care. Available at: https://www.acog.org/Patients/FAQs/Labor-Induction?IsMobileSet=false Last accessed: January 2020.
5 Propess summary of product characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/135/smpc. Last accessed: January 2020.
6 World Health Organization. Managing complications in pregnancy and childbirth: a guide for midwives and doctors – 2nd ed. Geneva: World Health Organization; 2017. Available at: https://www.who.int/maternal_child_adolescent/documents/managing-complications-pregnancy-childbirth/en/. Last accessed: January 2020