AbbVie and Neurocrine’s Oriahnn Receive the US FDA’s Approval as the First Oral Therapy for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women

AbbVie’s Dual Regimen Receives EC’s Approval for Patients with Previously Untreated Chronic Lymphocytic Leukemia

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

Click here to read full press release/ article | Ref: AbbVie | Image: PRNewswire