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.
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.
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 Sciences’ combination therapy met the main goal of a late-stage study testing the treatment in women with uterine fibroids.