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AbbVie's Orilissa Gets Canadian Nod to Treat Endometriosis

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AbbVie (ABBV - Free Report) along with its partner Neurocrine Biosciences, Inc. (NBIX - Free Report) announced that Health Canada has approved Orilissa (elagolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of moderate to severe pain associated with endometriosis. Orilissa was approved in the United States in July 2018 for the same indication. 

The approval was supported by positive data from two replicate phase III studies, 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. Orilissa is expected to be launched in Canada early November.

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 revenues for AbbVie.

Shares of AbbVie have lost 2.2% year to date versus the industry’s increase of 7.1%.


We remind investors that Orilissa is also being studied for the treatment of uterine fibroids in women. In August, the company announced positive top-line data from phase III extension study on Orilissa for the same. Outcomes data from the phase III ELARIS UF-EXTEND (M12-816) study 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.

Zacks Rank & Stocks to Consider

AbbVie currently has a Zacks Rank #3 (Hold).

Bristol-Myers Squibb Co. (BMY - Free Report) and Roche AG (RHHBY - Free Report) are better-ranked stocks from the same space, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $3.59 to $3.63 for 2018 and from $3.83 to $3.92 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.39%. Share price of the company has increased 2.0% year to date.

Roche’s earnings per share estimates have increased from $2.14 to $2.24 for 2018 and from $2.15 to $2.28 for 2019 over the past 60 days. Share price of the company has increased 1.8% year to date.

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