Dive Brief:
- The second Phase 3 trial for elagolix, AbbVie Inc. and Neurocrine Biosciences Inc.'s GnRH receptor antagonist, has proven positive, AbbVie announced on Tuesday, with the drug meeting both primary and secondary endpoints.
- In the ELARIS UF-II study, 76% of women with uterine fibroids receiving the combination of elagolix and add-back therapy had a clinical response of reduced blood loss compared with 10% receiving placebo at six months.
- The drug is awaiting approval with the Food and Drug Administration for the treatment of endometriosis, and has a user fee action date of next month. Analysts estimate the drug could surpass $1 billion in revenue by 2020.
Dive Insight:
The positive results in Phase 3, added to the ELARIS UF-I data reported last month, will bring AbbVie and partner Neurocrine Biosciences a step closer to the uterine fibroid market, and to treating a population with largely unmet needs.
"Millions of women currently diagnosed with uterine fibroids are faced with limited non-surgical options," said Dawn Carlson, VP ofgeneral medicine development. "The results from this study demonstrate elagolix has the potential to be an important oral treatment option for women suffering from uterine fibroids."
Analyst Geoffrey Porges at Leerink, in a company note, said that the data "increases our confidence in our current revenue forecasts for the product, which we now expect to launch in 2018 – first for endometriosis followed by uterine fibroids in 2020 – and to achieve revenue of $1.4 billion by 2023."
By the time elagolix hits the market, it could be faced with a handful of competitors, including Allergan plc's ulipristal acetate. This is pending approval for the treatment of abnormal uterine bleeding in women with uterine fibroids, with a user fee action date in the first half of 2018.
"The full data may help to further differentiate elagolix from GnRH agonist-based medicines, and should alter investors’ views of the future competitive landscape in this category," added Porges.
ELARIS UF-II is a replicate of ELARIS UF-I, and was carried out at approximately 100 sites in the United States and Canada. Phase 3 studies are ongoing.