Swiss Drugmaker ObsEva Seeks FDA Approval for Uterine Fibroids Therapy

Swiss biotech ObsEva has filed a new drug application with the FDA for linzagolix, which could become the first oral treatment in its drug class for women unable to take hormone therapy.

In two late-stage studies of the gonadotropin-releasing hormone antagonist in women with heavy menstrual bleeding linked to uterine fibroids, those who received the investigational treatment saw a significant reduction in menstrual bleeding compared to placebo.

Linzagolix is also being reviewed by the European Medicines Agency and ObsEva is anticipating an approval recommendation from the agency’s Committee for Medicine Products for Human Use this year.