backApril 25, 2022
Confirmation of Positive CHMP Opinion for GnRH Antagonist "Linzagolix" in Europe
Kissei Pharmaceutical Co., Ltd (Head Office: Matsumoto, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa) announces an update on the EU marketing authorisation process for the oral GnRH antagonist "Linzagolix (KLH-2109/OBE2109)", which was licensed to ObsEva (ObsEva SA, Headquarters: Geneva, Switzerland, CEO: Mr. Brian O'Callaghan). ObsEva recently announced confirmation of the previously adopted positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of Linzagolix for the treatment of uterine fibroids.
ObsEva submitted the marketing authorization application for linzagolix for uterine fibroids to the EMA in November 2020, and received a positive CHMP opinion recommending approval in December 2021. Following further review of the marketing authorization application, the positive CHMP opinion was confirmed at the April 2022 CHMP meeting.
In the Phase 3 clinical trials conducted, Linzagolix demonstrated efficacy both with and without hormonal add-back therapy. If approved, Linzagolix would be the first and only approved GnRH antagonist with a non-hormonal dosing option that can be used by women suffering from uterine fibroids who cannot or do not want to take hormones, thereby offering flexibility and choice to patients.
In Europe, ObsEva has entered into a licensing agreement with Theramex to support the commercialization and market introduction of Linzagolix.
For ObsEva press releases, please refer to their website.
The consolidated business forecast for fiscal year ending March 2023 including this matter will be disclosed at the Financial Results of fiscal year ending March 2022 to be held on 10th May 2022.
《 Reference 》
About Linzagolix (KLH-2109)
Linzagolix is a novel, orally administered GnRH receptor antagonist. Linzagolix acts by antagonizing the GnRH receptor in the pituitary gland, ultimately reducing estrogen production by the ovaries. In November 2015, Kissei licensed out exclusive rights to develop and market in countries excluding part of Asia such as Japan to ObsEva. ObsEva has conducted clinical development of Linzagolix for uterine fibroids and endometriosis. In the United States, the New Drug Application for Linzagolix for uterine fibroids is under review by the Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) target action date of September 13, 2022. Linzagolix is also in phase 3 clinical development for the endometriosis indication.
In Asia, Kissei licensed out rights to develop and market in China to Bio Genuine in September 2021, and is now in preparation to start clinical trials.
About Hormonal Add-back Therapy
Hormonal Add-back therapy, estradiol 1mg/ Norethisterone 0.5mg, is exogenous hormone replacement to prevent bone mineral density loss in patients treated with Linzagolix.
About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is traded under the ticker symbol "OBSN".
For more information, please visit https://www.ObsEva.com/
About Theramex
Theramex is a leading global specialty pharmaceutical company dedicated to women's health based in London, UK. They support women at every stage of their lives by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis. Theramex's commitment is to listen to and understand its patients, serve their needs and offer healthcare solutions to help improve their lives.
For more information of Theramex, please visit https://www.theramex.com/
