ObsEva plans to drop linzagolix, its leading candidate for the treatment of uterine fibroids, following concerns raised by the FDA.
ObsEva announced this week its plans to drop linzagolix as treatment for uterine fibroids, following the US Food and Drug Administration’s (FDA) concerns regarding deficiencies in the company’s New Drug Application for linzagolix. The company will undergo corporate restructuring to target its efforts on the reevaluation of its development and commercialization strategies.1
The company has been in close contact with the FDA and plans to submit additional data to address concerns within the application. In the meantime, ObsEva is unable to continue its labeling and post-market commitments and the original target action date of September 13 will be put on hold.
ObsEva also announced its decision to terminate its agreement with Kissei, from whom it licensed linzagolix in 2015. Its licensing agreement with Theramex, for the commercialization and marketing of linzagolix, will be transferred to Kissei.
These changes, ObsEva stated, will allow the company to meet its other obligations and support its other licensing agreements. Specifically, its current agreement with Organon for the development and commercialization of ebopiprant—an orally active, selective prostaglandin F2α receptor antagonist for the potential treatment of preterm labor—and its sublicense agreement with YuYuan BioScience for nolasiban—an oral oxytocin receptor antagonist to improve clinical pregnancy and live birth rates for women undergoing in-vitro fertilization.2,3
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