US approves AbbVie, Neurocrine Biosciences' Orilissa for pain associated with endometriosis

AbbVie and partner Neurocrine Biosciences announced Tuesday that the FDA approved the oral gonadotropin-releasing hormone receptor antagonist Orilissa (elagolix) for women with moderate-to-severe endometriosis pain. "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 US retail pharmacies in early August," the companies said. 

Approval was backed by data from two Phase III studies, involving a total of about 1700 women, which showed that Orilissa significantly reduced menstrual and non-menstrual pelvic pain associated with endometriosis. The drug is also being studied as a treatment for uterine fibroids, with the companies releasing positive results from the late-stage ELARIS UF-I and ELARIS UF-II trials earlier this year.

AbbVie and Neurocrine jointly developed Orilissa under a 2010 agreement worth as much as $575 million. Neurocrine CEO Kevin Gorman remarked that the FDA approval "reflects our joint commitment to develop therapies for difficult to manage conditions in underserved patient populations." 

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Last month, the Institute for Clinical and Economic Review (ICER) released a report questioning the long-term efficacy and safety profile of Orilissa for the management of endometriosis and associated pain, particularly in comparison to alternative treatments. According to the report, the drug "may be cost-effective compared to no treatment if priced in line with analyst expectations, but [a] large number of potentially eligible patients may pose short-term affordability challenges for health systems," the report said. For related analysis, see ViewPoints: ICER report may force AbbVie's hand on elagolix – in an odd direction

Orilissa will cost $845 every four weeks, without insurance, or about $10 138 per year. AbbVie predicts the drug will eventually garner annual revenue of $1 billion to $2 billion just from endometriosis. Meanwhile, analysts on average forecast that Orilissa could generate sales of $40 million by the end of the year, rising to $277 million in 2019 and to roughly $576 million in 2020. In the year following, estimates climb to as high as $1.23 billion.

For a look at the potential uptake of Orilissa, see Physician Views Results: With approval pending, doctors predict moderate adoption for AbbVie, Neurocrine elagolix.

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