Shots:

• The approval follows P-III ELARIS UF-I and ELARIS UF-II studies assessing Oriahnn (elagolix- estradiol- and norethindrone acetate capsules; elagolix capsules) vs PBO for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women for up to 24mos.
• The study met its 1EPs of clinically meaningful reduction in bleeding (defined as the proportion of women who achieved both at least a 50% reduction in menstrual blood loss at final month of treatment and a total menstrual blood loss amount of < 80 ml)- 7/ 10 vs 1/10 women no longer experiencing heavy menstrual bleeding- reduction in bleeding due to uterine fibroids by 50% within the first month of use
• The approval provides women with a non-surgical option addressing unresolved heavy menstrual bleeding. The therapy is expected to be available in the US by the end of Jun’2020

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