- The Food and Drug Administration on Tuesday approved AbbVie's gonadotropin-releasing hormone (GnRH) antagonist elagolix, giving a green light to the first oral treatment for moderate-to-severe endometriosis pain in over a decade.
- The drug, which will be sold under the name Orilissa, is expected to be available in U.S. pharmacies in August, and will carry a list price of about $850 per month, or just over $10,100 per year.
- While the price tag falls within the Institute for Clinical and Economic Review's value-based price benchmark range of $8,800 to $12,800, the drug cost watchdog also noted in a June report that the drug could still tax the healthcare system in the short-term based on the number of women afflicted with endometriosis.
Orilissa initially had a user fee goal date in April, but the FDA pushed out the approval by three months to better understand data around liver safety for the drug. On Tuesday, the agency approved two doses of the drug — 150 mg and 200 mg — but the label indicates that those with moderate hepatic impairment should only use the lower dose. It is not indicated for people with severe hepatic impairment.
The FDA is requiring AbbVie to conduct several post-marketing studies that look at the safety of the drug in pregnant women, as well as its impact on neonatal outcomes. The post-marketing requirements will also test its safety and tolerability when administered with oral contraceptives.
AbbVie partnered with Neurocrine Biosciences in June 2010, when it was still a part of Abbott Laboratories, to develop and market the drug. At the time, Abbott paid $75 million upfront and agreed to pay $500 million in development, regulatory and commercial milestones. This seems like a small price to pay for a drug that analysts peg could have sales well over $1 billion annually by 2022. The approval gives AbbVie an edge in an emerging market, and could be a sign of revitalized interest in the underserved area of women's health.
Orilissa is the first of several new drugs to hit the market for endometriosis pain. Previously, women who experience endometriosis pain were treated with non-steroidal anti-inflammatories, hormone treatments or surgery.
There are two other drugs in late-stages, as well as 11 drugs in the mid-stage pipeline, according to a report from Market Research HUB. ObsEva is one of those companies with a drug in mid-stage testing. The compound has the same mechanism of action as Orilissa, and has shown promising data so far. Astellas also has a GnHR antagonist in early- to mid-stage testing.
Until recently, women's health has largely been an overlooked therapeutic area. The space is dominated by contraceptive treatment options, but includes few medications for other diseases that afflict only women, like endometriosis and uterine fibroids. Along with AbbVie, Allergan has conducted research in the space but recently said it hopes to sell off its women's health assets.