Sales forecasts rise for AbbVie’s elagolix following expected approval in endometriosis

This article is part of an ongoing blog series profiling the 12 new, game-changing drugs predicted to achieve blockbuster status by 2022 in the 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics. Read the full Drugs to Watch report here or follow the series for the latest updates.

The 2018 edition of Drugs to Watch, the annual forecast and analysis from Clarivate Analytics, was released in March, detailing the anticipated blockbuster launches for 2018 according to Cortellis forecast sales data. Among the 12 drugs projected to reach blockbuster status by 2022 was AbbVie’s elagolix (Orilissa), a first-in-class gonadotropin-releasing hormone (GnRH) antagonist, which was approved as predicted in July 2018 for pain associated with endometriosis.1

The drug was approved for moderate-to-severe pain associated with endometriosis under FDA priority review and was launched in the U.S. in August. Endometriosis is an estrogen-dependent chronic disease in which symptoms such as pelvic pain and bleeding occur due to growth of endometrial cells in locations outside the uterus. Existing medical treatments are based on hormonal modulation to suppress estrogen release and ovulation, and include oral contraceptives and GnRH agonists such as Lupron and Zoladex. However, therapy duration with the GnRH agonists is usually limited due to adverse events, primarily bone mineral density (BMD) loss, and significant unmet need in the treatment of endometriosis remains.

The 2018 edition of Drugs to Watch, the annual forecast and analysis from Clarivate Analytics, was released in March, detailing the anticipated blockbuster launches for 2018 according to Cortellis forecast sales data. Among the 12 drugs projected to reach blockbuster status by 2022 was AbbVie’s elagolix (Orilissa), a first-in-class gonadotropin-releasing hormone (GnRH) antagonist, which was approved as predicted in July 2018 for pain associated with endometriosis.1

In AbbVie’s pivotal trial program, elagolix (150 mg) was shown to be effective in reducing non-menstrual pelvic pain (49.8%) and dysmenorrhea (43.4%) in premenopausal women2, while avoiding the hormonal symptoms (hot flush, headache) commonly associated with older treatments such as the GnRH agonist Lupron. The drug is also associated with only partial ovarian suppression, which avoids the significant bone loss associated with estrogen treatments, and co-administration with hormone add-back therapy (low-dose estradiol/norethindrone) is effective at further reducing BMD losses associated with treatment. Importantly, the label does not mandate BMD monitoring, which will differentiate the drug and should drive sales; the oral route of administration also presents convenience advantages versus the GnRH agonists which are injectable. However, duration of treatment has been limited by the FDA to a maximum of 24 months at the 150 mg dose, and prescribers are likely to favor oral contraceptives in the first line based on cost, at least until more safety data are available, which may limit mid-term sales.

The drug is also in development for uterine fibroids, for which filing is expected in 2019. First phase III data were reported in February 2018; the drug reduced blood loss in premenopausal women with heavy menstrual bleeding associated with uterine fibroids, with 68.5% and 76.2% of patients experiencing a clinically significant (>50%) reduction in menstrual blood loss in the ELARIS-UF I and II trials, respectively.3 An extension study which reported 12-month data in August 2018 was also positive.4 Although the fibroid indication is expected to be a meaningful contributor to sales, this market may be more limited as a direct competitor (Esmya, from Gideon Richter) was launched in Europe in 20125, and the drug label in this setting may be limited to use ahead of surgery for fibroid removal only.

“First phase III data were reported in February 2018; the drug reduced blood loss in premenopausal women with heavy menstrual bleeding associated with uterine fibroids, with 68.5% and 76.2% of patients experiencing a clinically significant (>50%) reduction in menstrual blood loss in the ELARIS-UF I and II trials, respectively.3

Cortellis Consensus Sales Forecasts (source Thomson Reuters I/B/E/S) for elagolix have risen since March when the Drugs to Watch 2018 report was issued, from $1.152 billion for 2022 to $1.358 billion for 2022, likely as the regulatory risk has been removed and longer-term data have been reported. (See Figure 1.) Further upside may be expected once regulatory expectations in uterine fibroids become more clear.

 

Read the full 2018 Drugs to Watch report here or follow this series for latest updates.

 

  1. https://news.abbvie.com/news/abbvie-receives-us-fda-approval-orilissa-elagolix-for-management-moderate-to-severe-pain-associated-with-endometriosis.htm
  2. https://news.abbvie.com/news/abbvie-announces-positive-top-line-results-from-second-phase-3-study-investigating-elagolix-in-patients-with-endometriosis.htm
  3. https://news.abbvie.com/news/abbvie-announces-positive-topline-results-from-phase-3-study-evaluating-investigational-elagolix-in-women-with-uterine-fibroids.htm
  4. https://news.abbvie.com/article_display.cfm?article_id=11698

https://www.preglem.com/2012/02/27/european-commission-approves-esmya-pre-operative-treatment-uterine-fibroids-myomas/

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