AbbVie Receives U.S. FDA Approval of ORILISSA

AbbVie Receives U.S. FDA Approval of ORILISSA

AbbVie Receives U.S. FDA Approval of ORILISSA

The FINANCIAL -- ORILISSA (elagolix) is the first FDA-approved oral treatment for the management of moderate to severe pain associated with endometriosis in over a decade

ORILISSA is available in two oral dosages-150 mg once daily and 200 mg twice daily, taken with or without food

FDA approval is supported by the largest endometriosis Phase 3 study program conducted to date

ORILISSA is expected to be available in U.S. retail pharmacies in early August 2018

According to AbbVie, a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), 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 and is expected to be available in U.S. retail pharmacies in early August 2018.

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

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, which can work for some women 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, and may not be curative for all individuals, according to AbbVie.

"Endometriosis is often characterized by chronic pelvic pain that can impact women's daily activities," said Hugh S. Taylor, M.D., study investigator and Chair of the Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine. "Women with endometriosis may undergo multiple medical treatments and surgical procedures seeking pain relief and this approval gives physicians another option for treatment based on a woman's specific type and severity of endometriosis pain."

The approval is supported by data from two replicate studies in the largest endometriosis Phase 3 study program conducted to date, which evaluated nearly 1,700 women with moderate to severe endometriosis pain. 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. A higher proportion of women treated with ORILISSA 150 mg once daily and 200 mg twice daily were responders for daily menstrual pain and non-menstrual pelvic pain compared to placebo in a dose-dependent manner at month three. 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 (nonsteroidal anti-inflammatory drug or opioid) 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. Women in the Phase 3 studies also provided a daily self-assessment of their endometriosis pain using a numeric rating scale (NRS) and women taking ORILISSA 150 mg once daily and 200 mg twice daily reported a statistically (p <0.001) significant reduction from baseline in NRS scores compared to placebo at month three. 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.

The recommended duration of use for ORILISSA is up to 24 months for the 150 mg once daily dose and up to six months for the 200 mg twice daily dose, as it causes a dose-dependent decrease in bone mineral density (BMD). BMD loss is greater with increasing duration of use and may not be completely reversible after stopping treatment. For women with moderate hepatic impairment, the recommended dosage is 150 mg once daily for up to six months. ORILISSA is recommended to be taken orally at approximately the same time each day, with or without food.

"Together with AbbVie, we are proud to offer a treatment option for the many women suffering from pain associated with endometriosis," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Neurocrine discovered ORILISSA nearly twenty years ago and through our partnership with AbbVie, the approval of ORILISSA reflects our joint commitment to develop therapies for difficult to manage conditions in underserved patient populations."