LONDON and TOKYO, Dec. 23, 2021 /PRNewswire/ -- Linepharma International Ltd., a global leader in medical abortion, announced today that its subsidiary Linepharma KK has applied for manufacturing and marketing approval in Japan for its oral drug MEFEEGO™ for the medical termination of pregnancies of up to 63 days of gestation. The medication is recognized as the international gold standard for first trimester medical abortioni and is on the World Health Organization (WHO) list of essential drugs for abortion.ii
A successful submission in Japan would signify the first approved medical abortion drug in Japan and would follow launches in Australia and Canada and most recently in South Korea, where a submission to health authorities will be made later this year. Available in 80 countries, the abortion pill has maintained an outstanding safety record throughout the world.iii
The drug combination of mifepristone and misoprostol, the first combination pack worldwide, will be known in Japan as MEFEEGO™. The application to the Pharmaceuticals and Medical Devices Agency (PMDA) is based on the results of a Japanese Phase III clinical trial consisting of 120 women aged 18 to 45 years old. If the drug is approved, the 156,430 Japanese women who had surgical abortion procedures in 2019 alone will have another therapeutic option based on their individual need.
"Linepharma is a global pioneer in abortion medicine and is dedicated to improving sexual and reproductive health including the discovery, development and distribution of innovative health solutions including a combination abortion medication. We are equally committed to working closely with health regulators, healthcare professionals, patient groups and other stakeholders to ensure access to safe and effective options", said Marion Ulmann, Linepharma International's General Manager. "Our drug application for MEFEEGO in Japan is a very significant milestone for Japanese women who, for the very first time, will have an entirely new option for abortion."
Around 73 million induced abortions take place worldwide each year. Global estimates demonstrate that 45% of all induced abortions are unsafe.iv According to the WHO, abortion is a simple and safe healthcare intervention that can be effectively managed by a wide range of healthcare professionals using medication or a surgical procedure.v
About Linepharma International Ltd.
Linepharma International Ltd. was established in 2010 and currently operates in more than 25 countries in North and South America and the Asia-Pacific region. In line with the most current scientific data and World Health Organization's recommendations, Linepharma supplies products for medication abortion in Canada, Latin America, Asia, and Australia. For more information visit www.linepharma.com
Linepharma KK
Linepharma KK was established in May 2020 and acquired a license as a pharmaceutical company in July 2021. Linepharma KK is committed to improving women's health through products and solutions focused on unmet medical needs including an oral drug for the medical termination of pregnancy.
REFERENCES |
i JOGC 2019 Barriers and Facilitators to the Implementation of first Trimester Medical Abortion with Mifepristone in the Province of Québec: A Qualitative Investigation Marie-Soleil Wagner, MD, MS; Sarah Munro, PhD; Elizabeth S. Wilcox, MA; Courtney Devane, RN, MN; Wendy V. Norman, MD, MH Sc; Sheila Dunn, MD, MSc; Judith A. Soon, RPh, PhD; Edith Guilbert, MD, MSc |
ii www.who.int/news-room/fact-sheets/detail/abortion |
iii www.actioncanadashr.org/resources/factsheets-guidelines/2019-04-06-faq-abortion-pill-mifegymiso |
iv Bearak J, Popinchalk A, Ganatra B, Moller A-B, Tunçalp Ö, Beavin C et al. Unintended pregnancy and abortion by income, region, and the legal status of abortion estimates from a comprehensive model for 1990–2019. Lancet Glob Health. 2020 Sep; 8(9):e1152-e1161. doi: 10.1016/S2214-109X (20)30315-6 |
Media contact and to arrange an interview: Carol Levine, Carol.levine@energipr.com, 1-514-703-0256, 1-416-425-9143 ext. 226