backFebruary 7, 2022
Update on EU marketing authorisation process for "Linzagolix" for the Treatment of uterine fibroids
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 that based on ongoing communications with the European Medicines Agency (EMA), further questions on the marketing authorisation application for linzagolix for the treatment of uterine fibroids may be forthcoming, thereby extending the application timeline. ObsEva is in dialogue with the EMA to understand areas that may require further clarification and is committed to promptly addressing any questions that could arise.
In the EU, ObsEva has applied for marketing authorization to the EMA in November 2020, and had received a positive opinion from the CHMP last December.
In the United States, the New Drug Application for linzagolix for the treatment of uterine fibroids was submitted to the United States Food and Drug Administration (FDA) in September 2021, and was accepted for review. The FDA set a target action date of September 13, 2022 for this NDA under the Prescription Drug User Fee Act (PDUFA).
To view the release by ObsEva, please refer to the website below.
URL https://www.obseva.com/press-releases/
This matter has negligible effects on Kissei's consolidated business forecasts for the fiscal year ending March 2022. If there are such circumstances that must be notified, it shall be disclosed promptly.
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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. The uterine fibroids Phase 3 program comprised two double-blind, placebo-controlled studies (PRIMROSE 1 and 2) to support the approval of Linzagolix for the treatment of heavy menstrual bleeding associated with uterine fibroids. ObsEva is also conducting a phase 3 clinical trial 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 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 www.ObsEva.com.
