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AbbVie Posts Positive Data on Elagolix for Uterine Fibroids

AbbVie Inc. ABBV and its partner Neurocrine Biosciences announced positive top-line data from phase III ELARIS UF-EXTEND extension study on Elagolix for the treatment of uterine fibroids in women. Outcomes from the phase III ELARIS UF-EXTEND (M12-816) trial demonstrated that Elagolix (300 mg twice daily) in combination with low-dose add-back therapy, reduced heavy menstrual bleeding in 87.9% of women with uterine fibroids at month 12 of the regime.

However, shares of AbbVie have lost 0.9% year to date versus the industry’s increase of 5.4%.

Elagolix was approved by the FDA in the United States for pain management associated with endometriosis, a common gynecologic disorder in July. It will be marketed by the trade name Orilissa.

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Top-line data from the extension study was in line with two pivotal phase III programs, ELARIS UF-I and ELARIS UF-II. The results demonstrated that both 68.5% and 76.2% of uterine fibroids patients having received elagolix with add-back therapy for a period of six months, experienced reduction in heavy menstrual bleeding, respectively.

Findings from the extension evaluation will be presented at a medical conference later this year and will also be presented at a future medical meet. AbbVie plans to submit a regulatory application for elagolix with respect to the aforementioned indication by 2019.

Per the company’s press release, uterine fibroids affect women at some point in their lives. Among them, some might experience symptoms such as heavy menstrual bleeding, painful periods, vaginal bleeding other than menstruation and anemia. At present, there are limited non-surgical treatment options for women suffering the ailment.

Elagolix has not been proven safe and effective as far as uterine fibroid is concerned. The disease is thus currently managed with oral contraceptives, progestins and GnRH agonists. Many such medicines are not specifically indicated for the treatment of uterine fibroid. Hence, approval of the candidate can address a market with significant unmet need and drive more sales for AbbVie.

We remind investors that another pharma company Allergan AGN also has Esmya/ulipristal acetate in its portfolio, presently under review for the treatment of uterine fibroids. Earlier this week, the FDA gave a complete response letter to the new drug application for Esmya on safety concerns. The regulatory body has requested additional information citing safety issues regarding Esmya’s post-marketing reports outside the United States.

AbbVie Inc. Price and Consensus

AbbVie Inc. Price and Consensus | AbbVie Inc. Quote

Zacks Ranks

 

AbbVie currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the pharma sector are Gilead Sciences, Inc. GILD and Illumina, Inc. ILMN, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Gilead Sciences’ earnings estimates have been moved 7.7% north for 2018 and 2.2% for 2019 over the past 60 days. The stock has gained 3% year to date.

Illumina’s earnings estimates have been raised 11.1% for 2018 and 8.7% for 2019 over the past 60 days. The stock has soared 53.6% so far this year.

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