The U.S. Food and Drug Administration granted approval to Myfembree, Myovant Sciences and Pfizer’s once-daily treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Patients receiving the therapy under the newly approved indication can take the medicine for up to 24 months.
ObsEva announced topline data from the PRIMROSE 1 and 2 Phase III trials of Yselty (linzagolix) for uterine fibroids.
Myovant announced topline results from SPIRIT 1, the second Phase III trial of once-daily relugolix combination therapy in women with pain linked with endometriosis.
AbbVie won a first-of-its-kind approval for a non-surgical treatment aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.
Switzerland-based Myovant announced an 88 percent one-year response rate in the positive Phase III LIBERTY extension study of once-daily, oral relugolix combination therapy in women with heavy menstrual bleeding associated with uterine fibroids.
ObsEva SA reported positive Phase 3 trial results from the PRIMROSE 2 trial of linzagolix for the treatment of heavy menstrual bleeding (HMB) due to uterine fibroids.
AbbVie announced the submission of a New Drug Application to the U.S. Food and Drug Administration for elagolix, an investigational GnRH antagonist for the management of heavy menstrual bleeding associated with uterine fibroids in women.
Myovant is preparing to seek regulatory approval for the company’s once-daily relugolix combination therapy for the treatment of uterine fibroids following positive Phase III results that showed a 71.2 percent response rate in patients.
