AbbVie’s Elagolix Dazzles in Phase III Trial

AbbVie and Neurocrine Biosciences, Inc. announced that its Phase III ELARIS UF-II trial of elagolix for uterine fibroids met its primary endpoint.

The companies had two pivotal Phase III trials, both of which showed at six months that 300 mg twice daily of elagolix, in combination with a low-dose hormone therapy, reduced heavy menstrual bleeding in 76.2 percent of women with uterine fibroids compared to 10.1 percent in those receiving placebo. The clinical response was measured by the alkaline hematin method. That response was defined as menstrual blood loss volume of less than 80 mL during the sixth month and a 50 percent or greater reduction from baseline to month six.

Uterine fibroids can affect up to 80 percent of women by age 50, and are the most common type of abnormal growth in a woman’s pelvis. They can be asymptomatic, but in about a quarter of women, they cause symptoms like heavy menstrual bleeding, painful periods, vaginal bleeding outside of menstruation, and anemia.

“Millions of women currently diagnosed with uterine fibroids are faced with limited non-surgical options,” said Dawn Carlson, AbbVie’s vice president, general medicine development, in a statement. “The results from this study demonstrate elagolix has the potential to be an important oral treatment option for women suffering from uterine fibroids.”

The topline results from this six-month analysis were consistent with the results from the ELARIS UF-I study that was reported last month. The study participants will continue in either post-treatment follow-up or in a blinded six-month extension study.

Some hypoestrogenic effects, such as hot flush and bone mineral density decreases were observed, but the overall safety profile was consistent with those seen in Phase II trials and the first Phase III trial. The data from the trial will be used to support regulatory submissions. Data continues to be collected in the trial.

Evaluate Pharma has projected that elagolix could hit $1.2 billion in peak sales. AbbVie is waiting for the U.S. Food and Drug Administration (FDA) to approve the drug for endometriosis in the second quarter. Endometriosis is a painful disease where the endometrium, which normally lines the inside of the uterus, grows outside the uterus, typically involving the ovaries, fallopian tubes and the pelvic lining.

John Carroll, with Endpoints News, writes, “AbbVie is already looking at a Q2 decision from the FDA on endometriosis. The company got this drug in a $575 million deal it struck in 2010 with Neurocrine, which stands to earn a royalty payout on an approval. AbbVie isn’t the only company in the clinic with a drug for uterine fibroids, though. Myovant, one of the biotechs launched by Vivek Ramaswamy, is pursuing work on their own drug—relugolix—after doing a partnership with Takeda Pharmaceutical . But it will have to differentiate itself from AbbVie’s drug.”

In November 2017, Myovant Sciences reported positive top-line data from its Phase III trial of relugolix for pain associated with uterine fibroids. It is being evaluated in two international, replicate pivotal clinical trials, LIBERTY 1 and 2, in women with heavy menstrual bleeding associated with uterine fibroids.