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AbbVie Submits NDA for Endometriosis Candidate to the FDA

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AbbVie Inc. (ABBV - Free Report) and partner Neurocrine Biosciences announced that the new drug application (NDA) for their pipeline candidate, elagolix, has been submitted to the FDA. AbbVie is looking to get elagolix approved as an oral medicine for the management of pain associated with endometriosis.

The NDA filing is supported by positive results from two replicate pivotal phase III trials evaluating elagolix, a gonadotropin-releasing hormone (GnRH) antagonist, in this indication. The detailed data from the study, presented in October last year, showed that treatment with elagolix resulted in statistically significant reductions in menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. Data from the studies also demonstrated superiority compared to placebo in reducing painful intercourse associated with endometriosis.

Endometriosis affects an estimated one in 10 women of reproductive age and is associated with pain symptoms. At present there is no cure for endometriosis. The pain associated with endometriosis is currently managed with oral contraceptives, progestins, danazol, NSAIDS, opioids, and GnRH agonists. Many of these medicines are not specifically indicated for the treatment of endometriosis.

So far this year, AbbVie’s share price has increased 23%, comparing favorably with a gain of 11.8% recorded by the industry.

Elagolix is also being evaluated in phase III studies for reducing heavy menstrual bleeding in premenopausal women with uterine fibroids. Data from the pivotal study is expected by end of 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 (RHHBY - Free Report) , Bristol-Myers (BMY - Free Report) and Biogen (BIIB - Free Report) .

AbbVie 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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