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AbbVie Secures FDA Approval for Endometriosis Drug Elagolix

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AbbVie Inc. (ABBV - Free Report) together with its partner Neurocrine Biosciences announced that the FDA has approved its pipeline candidate, elagolix, for the treatment of moderate to severe pain associated with endometriosis, a common gynecologic disorder in women.

The candidate to be marketed by the trade name of Orilissa is expected to hit the retail markets in the United States from this early August onward.

The approval was granted on a priority review basis. It was supported by positive results from two replicate studies in the largest endometriosis phase III trials, which evaluated Orilissa for the given indication in women. The detailed data from the analysis showed that treatment with Orilissa resulted in statistically significant reductions in menstrual and non-menstrual pelvic pain associated with endometriosis compared with placebo.

Endometriosis affects an estimated one in 10 women of reproductive age and is associated with pain symptoms. The pain associated with it is currently managed with oral contraceptives, progestins, danazol, NSAIDS, opioids and GnRH agonists. Many medicines are not specifically indicated for treating endometriosis. With Orilissa approved to treat pain associated with endometriosis, it can address a market with significant unmet need to bring in more sales for AbbVie.

Notably, last September, the FDA accepted AbbVie's new drug application (NDA) for Orilissa and subsequently, granted priority review status in October. However, in April this year, the regulatory body extended its review period of marketing application for Orilissa by three months.

The FDA requested for a prolonged time frame to review additional information provided by AbbVie along with its NDA related to the results of liver function tests.

Shares of AbbVie have decreased 5.4% so far this year versus the industry’s decline of 1.4%.    

AbbVie currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the pharma sector include Vanda Pharmaceuticals Inc. (VNDA - Free Report) , Illumina, Inc. (ILMN - Free Report) and Eli Lilly and Company (LLY - Free Report) . While Vanda Pharmaceuticals and Illumina sport a Zacks Rank #1 (Strong Buy), Eli Lilly carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Vanda Pharmaceuticals’ earnings estimates have been revised 11.1% upward for 2018 and 3.9% for 2019 over the past 60 days. The stock has surged 34.5% so far this year.

Illumina’s earnings estimates have been moved 0.2% north for 2018 and 0.4% for 2019 over the past 60 days. The stock has soared 41.3% so far this year.

Eli Lilly and Company’s bottom line per share estimates have been raised 0.2% for 2018 and 1.6% for 2019 over the past 60 days. The stock has rallied 10.6% year to date.

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