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FDA Approves New Drug to Treat Endometriosis Pain

27 July 2018

Abbvie said the product is expected to be available in USA retail pharmacies early next month.

Orilissa (elagolix) became the latest potential blockbuster to pass FDA scrutiny and the first oral drug in more than a decade approved to treat moderate to severe pain associated with endometriosis.

Data from two studies of almost 1,700 women with moderate to severe endometriosis pain supported the FDA's approval.

The FDA approved elagolix under priority review.

"Together with AbbVie, we are proud to offer a treatment option for the many women suffering from pain associated with endometriosis", said Kevin Gorman, PhD, Chief Executive Officer of Neurocrine Biosciences. "The approval of ORILISSA demonstrates AbbVie's continued commitment to address serious diseases and unmet needs".

The drug was tested in two replicate studies in a Phased 3 study program that evaluated over 1,700 women with moderate to severe endometriosis.

Orilissa is recommended for up to 24 months for the 150 mg, once-daily dose and up to six months for the 200 mg, twice-daily dose.

"Endometriosis is often characterised by chronic pelvic pain that can impact women's daily activities", said Hugh Taylor of Yale School of Medicine, one of the investigators in Orilissa's phase III programme. Patients were randomized to receive either Orilissa 150mg once daily, Orilissa 200mg twice daily, or placebo; the co-primary endpoints were the proportion of patients whose dysmenorrhea responded to treatment at Month 3 and the proportion of patients whose non-menstrual pelvic pain responded to treatment at Month 3.

Endometriosis is one of the most common gynaecologic disorders in the USA, affecting around one in 10 women of reproductive age.

Endometriosis - a condition where tissue lining the womb migrates elsewhere, such as the ovaries and fallopian tubes - has a range of therapies available, including pain medication and hormonal therapies.

AbbVie (ABBV), in cooperation with Neurocrine Biosciences, Inc.

Shares of AbbVie were up 2.39 percent on Tuesday to close the trading session at US$91.54. The company now has a moderate buy ranking on TipRanks based off seven analyst ratings with an average price target of US$107.83, a high estimate of US$135, and low estimate of US$78.

FDA Approves New Drug to Treat Endometriosis Pain