AbbVie Wins U.S. Approval for Endometriosis Pain Treatment

(Bloomberg) -- AbbVie Inc. won U.S. approval for an oral medicine that treats pain caused by the gynecological disorder endometriosis, a step toward giving the maker of the blockbuster arthritis treatment Humira another potential billion-dollar sales hit.

The Food and Drug Administration has approved elagolix to treat pain associated with endometriosis, a common condition in which the tissue that lines the uterus grows in other parts of the body. It’s the first such treatment approved in more than a decade, the company said Tuesday in a statement. Marketed under the brand name Orilissa, the medicine should be available in pharmacies at the beginning of August, the drugmaker said.

Elagolix was named one of the top 10 prospective drug launches of the year by the analytical firm Evaluate in its 2018 preview, with projected annual sales of $934 million by 2022. Humira, the world’s best-selling drug, is expected to bring in $20.3 billion in sales this year, though it faces looming competition from generic rivals known as biosimilars.

The FDA approval is the latest development in a process that began in 2010, when AbbVie acquired global rights to elagolix from Neurocrine Biosciences Inc. for $75 million in cash, and about $500 million in development, regulatory and commercial milestones. In anticipation of the drug’s approval, AbbVie has been running an awareness campaign for the condition urging women to speak up about the pain rather than minimizing the condition.

Sanjay Agarwal, director of fertility services at the University of California San Diego’s Department of Reproductive Medicine and a clinical investigator for elagolix, said that awareness is important because many women hide or dismiss pain associated with the condition.

AbbVie’s shares climbed 1.8 percent to about $91.01 at 3:05 p.m. in New York after the company announced the approval. For the year, they are down about 6 percent.

No Cure

There’s no cure for endometriosis. Instead, treatments focus on curbing the sometimes debilitating pain associated with it. Many of those treatments, though, are often ineffective or come with side effects that prevent long-term use. In extreme cases, patients can opt for surgery.

Elagolix is what’s known as a gonadotropin-releasing hormone receptor antagonist. It works by reducing the production of ovarian-stimulating hormones estrogen and progesterone, reducing pain. However, unlike other therapies with the same target, elagolix only partially blocks those hormones, resulting in fewer side effects and safer long-term use.

In September, North Chicago, Illinois-based AbbVie submitted elagolix for FDA approval on the heels of phase 3 trials that showed it was well-tolerated and reduced three types of pain associated with endometriosis: daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse. The agency originally granted the application priority status, shortening the review time to six months. In April, however, the FDA said it needed more time to review the results of liver function tests.

Endometriosis often goes undiagnosed, but estimates suggest it may affect more than one in 10 women between the ages of 15 and 44. Analysts on average estimate AbbVie’s drug could generate $40 million in sales by the end of the year. In 2019, that estimate climbs to $277 million, and for 2020, analysts project sales around $576 million. In the year following, estimates climb to as high as $1.23 billion.

In addition, the drug is being studied as a treatment for uterine fibroids, and AbbVie released positive data from those trials earlier this year. The drug could play an important role in the company’s portfolio, cushioning the blow from Humira biosimilars.

©2018 Bloomberg L.P.