AbbVie's Orilissa makes its uterine fibroids case with double phase 3 win

AbbVie expects Orilissa to exceed $2 billion in sales by 2025. (AbbVie)

AbbVie’s Orilissa (elagolix) snagged its first FDA approval over the summer, and now it’s looking to make it two.

On Wednesday, the Illinois drugmaker and partner Neurocrine Biosciences unveiled details from a pair of phase 3 studies showing that the drug—already approved as a treatment for endometriosis-related pain—had topped placebo at reducing heavy menstrual bleeding related to uterine fibroids.

In both studies, researchers were looking for a response that included menstrual blood loss volume of less than 80 mL during the final month of a six-month treatment period, as well as a 50% or greater reduction in blood loss volume between the starting point and end of the treatment period. In one study, 68.5% of women taking Orilissa hit those benchmarks, compared with just 8.7% of women taking placebo. And in the second, 76.2% of patients in the Orilissa arm responded, versus 10.1% of placebo patients.

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"The results support AbbVie's continued efforts to pursue regulatory filing of elagolix and its potential to help women manage heavy menstrual bleeding associated with uterine fibroids,” Dawn Carlson, M.D., M.P.H., VP of general development at AbbVie, said in a statement, adding that “More non-invasive treatment options are needed for women with uterine fibroids who experience symptoms.”

With that data in hand, the companies expect to file for FDA approval in the middle of next year, AbbVie said.

AbbVie scored its first FDA go-ahead for Orilissa in July, becoming the first new oral option for endometriosis patients in more than a decade. At the time, Goldman Sachs analyst Jami Rubin wrote to clients that the drug was “well positioned to hit management expectations of >$2bn by 2025,” adding that she and her colleagues foresaw the med cracking the blockbuster barrier in 2020.

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In uterine fibroids, though, the therapy could face some newer competition—that is, if Allergan can usher in a long-delayed nod for Esmya before AbbVie gets a green light. In August, U.S. regulators shot down the Dublin drugmaker’s prospect, asking for additional info and citing liver damage cases in Europe, where Esmya is already approved.