ObsEva Submits NDA Of Linzagolix To FDA For Treatment Of Uterine Fibroids

ObsEva SA (OBSV) said Wednesday that it has submitted a New Drug Application to the U.S. Food and Drug Administration for linzagolix for the treatment of uterine fibroids.

Linzagolix is an oral GnRH receptor antagonist with potential best-in-class efficacy, favorable tolerability profile, and unique and flexible dosing options.
Further, if approved, linzagolix will be the only GnRH antagonist in uterine fibroids with a low dose non-add-back therapy (ABT) option.

ObsEva said that it is also working closely with the European Medicine Agency's to achieve marketing approval. Linzagolix previously received validation of the marketing authorization application (MAA) with an approval recommendation from the Committee for Medicinal Products for Human Use expected in the fourth-quarter 2021.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
CVS Health is set to recruit qualified candidates to fill 25,000 clinical and retail jobs during a one-day national career event on Friday, September 24. This will enable CVS to meet the high demand for pharmacists, pharmacy technicians, nurses, and retail store associates to support flu season, COVID-19 vaccinations and testing. Twitter, Inc. (TWTR) announced Monday that it has entered into a binding agreement to settle the consolidated class action lawsuit commenced in 2016 in the United States District Court for the Northern District of California. Under the terms of the proposed settlement, Twitter will pay $809.5 million... Drug major Pfizer has again expanded the earlier two recalls of its anti-smoking Drug Chantix (Varenicline) in the form of tablets, to now include all the lots, for the potential presence of nitrosamine impurity, N-Nitroso- varenicline, at or above the FDA interim acceptable intake limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.
Follow RTT