An AbbVie drug that treats pain in the uterus has notched an additional FDA approval for addressing heavy menstrual bleeding associated with uterine fibroids.
The regulatory decision Friday covers that drug, elagolix, combined with estrogen and progestin in a capsule that North Chicago, IL-based AbbVie (NYSE: ABBV) plans to market as Oriahnn. Elagolix (Orilissa) was approved in 2018 as a treatment for moderate-to-severe pain associated with endometriosis, a condition in which tissue that normally lines the uterus grows outside of it. The regulatory nod in uterine fibroid bleeds makes elagolix the first FDA-approved drug for that indication.
Uterine fibroids are non-cancerous tumors that develop in the uterus. In addition to heavy bleeding, fibroids can cause pain, bladder problems, and infertility. When symptoms are severe, women can opt for a hysterectomy—surgical removal of the uterus. But not all women qualify for the procedure, and some who do may not want to undergo surgery.
Elagolix is a small molecule that binds to gonadotropin-releasing hormone receptors in the pituitary gland, leading to a reduction in estrogen levels. These lower estrogen levels translate into a reduction in endometriosis pain, AbbVie says. In uterine fibroids, the lower hormone levels are also associated with a reduction in bleeding. Elagolix was initially discovered by San Diego-based Neurocrine Biosciences (NASDAQ: NBIX), which licensed it to AbbVie in 2010. The drug generated $93 million in sales last year, according to AbbVie’s annual report.
The FDA based its approval of Oriahnn on the results of two Phase 3 clinical trials enrolling 591 premenopausal women who experienced heavy menstrual bleeding, which was defined as at least two cycles with greater than 80 milliliters (mL) of menstrual blood loss. Patients were randomly assigned to receive either the drug or a placebo for six months. The main goal of the study was achieving blood loss of less than 80 mL in the final month and a 50 percent or greater reduction in blood loss from the start of the study.
The FDA said 68.5 percent of patients who received the AbbVie drug achieved the study goal, compared to 8.7 percent of those given a placebo. In the second study, 76.5 percent of patients hit the goal versus to 10.5 percent of placebo recipients. Results from the study were published in January in the New England Journal of Medicine.
The most common side effects reported were hot flushes, headache, fatigue, and irregular vaginal bleeding. The AbbVie drug does come with some risks. The FDA warns that the drug may cause bone loss over time, which increases patients’ risk of fractures. Consequently, women are advised against taking the drug for more than 24 months. The FDA also says clinicians can monitor bone density during the course of treatment.
Oriahnn’s label includes a boxed warning about the risk of strokes and blood clots. The FDA says patients should stop taking the drug if a blood clot, heart attack, or stroke occurs. The agency further warns that the drug should not be used by women with a history of blood clots or those at increased risk for blood clots. Others who should not use the drug include women who have osteoporosis; a history of breast cancer or other cancer that is sensitive to hormones; liver disease; or undiagnosed abnormal uterine bleeding.
AbbVie isn’t the only company targeting receptors in the pituitary gland with a small molecule drug. Myovant Sciences (NYSE: MYOV) has tested its drug, relugolix, as a treatment for uterine fibroids, endometriosis, and advanced prostate cancer. Relugolix is currently being reviewed by the European Medicines Agency as a potential uterine fibroids treatment, and the company said in its fiscal fourth quarter financial report that it plans to file for FDA approval in that indication this spring. An application for the Myovant tablet has already been filed with the FDA in advanced prostate cancer.
AbbVie says it expects Oriahnn will become available by the end of June.
Photo by AbbVie