ObsEva Ends Linzagolix Launch Plans, Casting Another Shadow Over Women's Health

The Swiss drug maker will initiate a "mass dismissal" and return rights to its lead drug candidate after the US FDA alerted the company to NDA deficiencies.

car crash — ObsEva's launch plans have crashed • Source: Shutterstock

Swiss women's health specialist ObsEva SA had been preparing for the near-term launch of its first commercial product – the GnRH antagonist linzagolix for bleeding associated with uterine fibroids – but after hitting a regulatory roadblock the company is now restructuring and returning rights to the drug to its partner Kissei Pharmaceutical Co., Ltd instead.

The news announced on 27 July is a huge blow for ObsEva, as linzagolix is the company's primary asset, but...