After 2nd positive PhIII, AbbVie points endometriosis drug elagolix to a 2017 NDA

AbbVie says it has racked up a second set of positive Phase III data for its endometriosis drug elagolix, setting up a regulatory filing for sometime next year.

AbbVie ($ABBV) partnered with Neurocrine ($NBIX) on this drug back in 2010, taking over development back when it was Abbott ($ABT) and promising to pay up to $575 million for a successful program.

Investigators put two doses of this drug into mirror Phase IIIs. In the latest, global study the pharma company said that both doses of the treatment--150 mg and 200 mg--significantly reduced patient scores on menstrual pain (dysmenorrhea, DYS) and nonmenstrual pelvic pain (NMPP) compared with a placebo.

At least one analyst believes that the drug, an oral gonadotropin-releasing hormone (GnRH) antagonist, can go on to a blockbuster future. Deutsche Bank analyst Robyn Karnauskas has pegged peak sales for endometriosis at $1.2 billion in the U.S. and Europe, according to a report from BioWorld.

A total of some 1,700 women were enrolled for the two studies, suffering from a disease in which tissue that normally grows inside the uterus starts to grow outside the uterus.

AbbVie's Michael Severino

"Endometriosis affects an estimated 176 million women worldwide," said Michael Severino, the chief scientific officer at AbbVie, in a statement. "In an effort to address this need, AbbVie conducted the largest clinical trials in endometriosis to date. We are pleased with the outcomes of the pivotal trials thus far. AbbVie will continue to pursue Elagolix as a potential new treatment for the disease's most common symptoms, including pain related to menstruation and chronic pelvic pain throughout the menstrual cycle."

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