ObsEva Expects Delay In Linzagolix Application Submission In Europe For Uterine Fibroids

ObsEva SA OBSV said that based on ongoing communications with the European Medicines Agency (EMA), it expects further questions on the linzagolix application, 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 December, EMA's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of linzagolix for uterine fibroids.
• In the U.S., the linzagolix application for uterine fibroids has been accepted for review by the FDA, with a PDUFA target action date of September 13, 2022.
• Last month, ObsEva announced results from the Phase 3 EDELWEISS 3 trial of linzagolix for moderate-to-severe endometriosis-associated pain (EAP). 
• Two doses were tested, a 200 mg once-daily dose of linzagolix combined with add-back therapy (ABT) and a 75 mg dose of linzagolix without ABT.
• The 200 mg and 75 mg doses demonstrated reductions in dysmenorrhea. 
• Also, 200 mg showed reduced non-menstrual pelvic pain at three months. However, 75 mg did not reach statistical significance versus placebo. 
• Price Action: OBSV shares are down 2.10% at $1.40 during the premarket session on the last check Monday.