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AbbVie's Elagolix Meets Primary Endpoint in Phase II Study

Zacks Equity Research

AbbVie Inc. ABBV along with Neurocrine Biosciences, Inc. NBIX announced positive results from a phase IIb study evaluating its pipeline candidate elagolix for reducing heavy menstrual bleeding in premenopausal women with uterine fibroids. The data from the study were presented at the third Congress of the Society of Endometriosis and Uterine Disorders (SEUD).

We note that AbbVie's shares have outperformed the Zacks classified Large Cap Pharma industry so far this year. AbbVie's shares returned 5.8% year to date, better than 4.7% gain for the industry.

Data from the study showed that elagolix met its primary endpoint by significantly reducing the number of heavy bleeding days rapidly within the assessment period of six months from the baseline in comparison to a placebo, utilizing the alkaline hematin method. The treatment also increased hemoglobin concentration in such patients.

The randomized, double-blind phase IIb uterine fibroids study (M12-813) evaluated elagolix treatment regimens in two parallel groups with dosage of 300mg twice daily and 600mg once daily. It studied elagolix alone as well as in combination with two add-back therapies (estradiol / norethindrone acetate). Data from only 300 mg cohort were presented while 600 mg cohort results will be published later.

The ongoing phase III program on elagolix for uterine fibroids includes two replicate, pivotal, six-month efficacy and safety studies followed by a six-month safety and efficacy extension study

Elagolix is also being evaluated for the treatment of premenopausal women who suffer from endometriosis. In October last year, AbbVie  and Neurocrine Biosciences announced positive results from two replicate pivotal phase III trials evaluating elagolix in this indication. The detailed data showed that treatment with elagolix resulted in statistically significant reductions in menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo at month three and month six. AbbVie plans to submit a NDA to the FDA for endometriosis in 2017.

Apart from elagolix, AbbVie has several candidates in different stages of development across a wide range of therapeutic areas and has partnerships with companies like Roche, Bristol-Myers Squibb Company BMY and Biogen Inc. BIIB.

AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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