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Following some clean sweeps in PhIII, AbbVie gets an FDA OK on its top-10 blockbuster prospect Orilissa

One of the year’s top prospective blockbuster approvals just came through.

AbbVie $ABBV says that they just nabbed an FDA OK for elagolix — the first new oral drug approved for endometriosis pain in more than a decade. 

The drug will be rolled out into the marketplace under the name Orilissa, which analysts tap as a likely $1.2 billion-plus drug, fitting well into EPVantage’s list of top 10 experimental drugs for 2018.

A spokesperson for AbbVie tells me that the price has been set at about $850 a month.

Hugh Taylor

The approval is also good news for Neurocrine Biosciences $NBIX, the biotech that discovered the drug and out-licensed it to AbbVie, which has been working on a pipeline of new therapies in anticipation of the day — about 5 years from now — when they will lose patent protection on their cash cow Humira.

Right on the heels of their application on endometriosis, the company followed up with back-to-back studies showing the drug’s promising impact on uterine fibroids, which AbbVie will look to for its next supplemental approval.

“Endometriosis is often characterized by chronic pelvic pain that can impact women’s daily activities,” said Hugh Taylor, 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.”


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