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Clinical Trial Data Shows Efficacy of Elagolix to Treat Uterine Fibroids

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Elagolix timelines

Together, AbbVie (ABBV) and Neurocrine Biosciences (NBIX) aim to develop Elagolix as a minimally invasive yet effective therapy for uterine fibroids (or UF). Elagolix is expected to receive regulatory approval from the FDA as a therapy for endometriosis associated pain (or EAP) in second half of 2018.

 

If Elagolix can meet the anticipated regulatory deadlines, it may have positive impact on AbbVie (ABBV) stock. It is also expected to benefit the iShares Russell 1000 ETF (IWB). AbbVie makes up ~0.46% of IWB’s total portfolio holdings.

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Phase 2b Results

The Elagolix 300 mg twice-a-day therapy achieves an ~90% response rate in reducing heavy menstrual bleeding. If combined with add-back therapy, there is modest decline in response rate to ~80%. However, in case of the latter treatment option, there is far less loss of bone mineral density in women using the therapy.

According to the Center for Young Women’s Health, “Add-back therapy is the addition of a small amount of the hormones estrogen and progesterone or progesterone alone.”

Success in the women’s health segment is expected to help AbbVie reduce its over-reliance on the Humira franchise. AbbVie expects to become a diversified pharmaceutical player similar to peers Merck (MRK) and Novartis (NVS).

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