AbbVie Announces Positive Results from Second Phase 3 Uterine Fibroids Study

Edward Kim  |

AbbVie (NYSE: ABBV) announced today positive results from its second Phase 3 trial of elagolix, an orally administered gonadotropin-releasing hormone (GnRH) antagonist for the treatment of women with uterine fibroids. At six months, a dosage of 300mg twice daily of elagolix in combination with low-dose hormone therapy (estradiol 1.0 mg / norethindrone acetate 0.5 mg) achieved the primary study endpoint of reduced heavy menstrual bleeding with 76.2% (p<0.001) of women with uterine fibroids achieving clinical response compared to 10.1% for placebo. Clinical response was defined as menstrual blood loss volume of less than 80 mL during month six and a 50% or greater reduction in menstrual blood loss volume from baseline to month six. The study also met all ranked secondary endpoints (p<0.02) at month six.

Uterine fibroids are the most common type of abnormal growth in a woman's pelvis and can affect up to 80% of women by age 50, according to the National Women's Health Network. Fibroids can cause heavy menstrual bleeding, painful periods, vaginal bleeding at times other than menstruation and anemia in 25% of women, and African American women are more likely to experience fibroids and do so at a younger age.

Millions of women currently diagnosed with uterine fibroids are faced with limited non-surgical options. The results from this study demonstrate elagolix has the potential to be an important oral treatment option for women suffering from uterine fibroids.

- Dawn Carlson, MD, MPH, vice president, general medicine development, AbbVie

The topline results from this six-month primary analysis were consistent with topline results from the first Phase 3 study reported in February 2018, and will be presented at an upcoming medical conference. Women in the study will continue in either post-treatment follow-up or a blinded six-month extension study.

AbbVie licensed elagolix from Neurocrine Biosciences (Nasdaq: NBIX) in 2010. According to John Carroll of Endpoints News, Evaluate Pharma called elagolix one of the top 10 likely rollouts for 2018, with $1.2 billion in peak projected sales.

Please email us at to see our Case Studies and Testimonials.

Please click here for information on our new trading platform.

Please click here to see our weekly newsletter.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not necessarily represent the views of Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to:

Market Movers

Sponsored Financial Content