AbbVie seeks approval to market new drug elagolix in the USA

Chicago, USA-based AbbVie (NYSE: ABBV) has filed for regulatory approval in the USA for elagolix, an investigational therapy for endometriosis-associated pain, under development in collaboration with Neurocrine Biosciences (Nasdaq: NBIX).

Following the announcement, shares in AbbVie ticked up 2%, and in Neurocrine 1%.

Endometriosis occurs when tissue similar to that normally found in the uterus begins to grow outside of the uterus, leading to long-term pelvic pain (during or between periods), pain with intercourse and other painful symptoms.

The orally administered gonadotropin-releasing hormone (GnRH) antagonist is being studied in two replicate Phase III clinical studies.

AbbVie says the drug has demonstrated superiority compared to placebo in reducing three types of endometriosis-associated pain – daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse.

In addition, the safety profile of elagolix was reported to be consistent with the partial hormone suppression associated with its mechanism of action.

AbbVie executive vice president Michael Severino said: "Elagolix has the potential to be an important oral treatment option for women suffering from the most prevalent symptoms of endometriosis and we look forward to working with the FDA throughout the review process."

Phase III trials of elagolix for the management of uterine fibroids are ongoing.

SEPTEMBER 06, 2017

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