FDA approves ORILISSA for the management of endometriosis

AbbVie, a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) approved ORILISSA ™ (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain.

The FDA approved ORILISSA under priority review. ORILISSA represents the first FDA-approved oral treatment for the management of moderate to severe pain associated with endometriosis in over a decade.

Endometriosis is one of the most common gynecologic disorders in the U.S. It affects an estimated one in 10 women of reproductive age and can be associated with pain symptoms that can be debilitating. Women can suffer for up to six to 10 years and visit multiple physicians before receiving a proper diagnosis.

Endometriosis-associated pain is often managed with medicines such as oral contraceptives, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids and hormonal therapies, but very few are specifically indicated for the treatment of endometriosis. In more extensive cases, surgical interventions (e.g., laparotomy, laparoscopy or hysterectomy) are often pursued.

The approval is supported by data from two replicate studies in the largest endometriosis Phase 3 study program conducted to date. Clinical trial data demonstrated ORILISSA significantly reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain and pain with sex. Women were defined as responders if they experienced a reduction in daily menstrual pain and non-menstrual pelvic pain with no increase in analgesic use for endometriosis-associated pain.

Both ORILISSA treatment groups showed statistically significant greater mean decreases from baseline compared to placebo in daily menstrual pain and non-menstrual pelvic pain at month six. Clinical trial data also demonstrated women taking ORILISSA 200 mg twice daily showed statistically significant greater reduction in pain with sex from baseline to month three compared to placebo.

Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie said, “ORILISSA represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease. The approval of ORILISSA demonstrates AbbVie’s continued commitment to address serious diseases and unmet needs.”

Hugh S. Taylor, M.D., study investigator and Chair of the Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine commented, “Women with endometriosis may undergo multiple medical treatments and surgical procedures seeking pain relief and this approval gives physicians another option for treatment.”