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 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

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  • 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

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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