11:08 AM
Mar 13, 2018
 |  BC Extra  |  Clinical News

AbbVie's elagolix meets in second Phase III for uterine fibroids

AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the primary and all ranked secondary endpoints in the Phase III ELARIS UF-II (M12-817) trial, the second of two replicate Phase III trials of the candidate to treat uterine fibroids. AbbVie said a commercial launch of elagolix to treat uterine fibroids is planned for 2020, but the company declined to disclose a timeline for regulatory submissions.

In February, AbbVie said elagolix met the primary and all ranked secondary endpoints in the first trial, ELARIS UF-I (M12-815) (see BioCentury Extra, Feb. 21).

On ELARIS UF-II's primary endpoint, twice-daily 300 mg oral elagolix plus estradiol/norethindrone acetate significantly reduced heavy menstrual bleeding at six months as measured by the proportion of patients achieving a clinical response per the alkaline hematin method vs. placebo (76.2% vs. 10.1%, p<0.001). A clinical response was defined as menstrual blood loss volume of less than 80 mL during month six and at least a 50% reduction in menstrual blood loss volume from baseline to six months. Ranked secondary endpoints included measures of bleeding, bleeding suppression and hemoglobin changes.

The trial enrolled about 385 premenopausal women ages 18-51 with heavy menstrual bleeding associated with uterine fibroids to receive placebo, elagolix alone or elagolix in combination with low-dose hormone therapy. AbbVie plans to present the data at an upcoming medical conference.

An NDA for elagolix is under FDA Priority Review for the management of endometriosis with associated pain. Its PDUFA date is next quarter (see BioCentury Extra, Oct. 27, 2017).

AbbVie has exclusive, worldwide rights to the non-peptide small molecule gonadotropin-releasing hormone (GnRH) antagonist from Neurocrine Biosciences Inc. (NASDAQ:NBIX).

Neurocrine dipped $0.23 to $90.36 on Tuesday.

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