With Allergan’s rival on the regulatory ropes, AbbVie posts more promising late-stage data for elagolix

AbbVie picked a good day to unveil another positive set of late-stage data from their uterine fibroid program for elagolix, now on the market as Orilissa for a different indication.

Just hours after Allergan revealed that their application for a rival therapy had been hit with a rejection letter from the FDA, the AbbVie team says their Phase III ELARIS UF-EXTEND extension study of elagolix hit a clinical response rate of 88%. That comes on top of two clearly upbeat Phase III readouts showing a high rate of responses, defined by a significant drop in menstrual blood loss.

Women often develop uterine fibroids without any symptoms occurring, but roughly 1 in 4 do have some serious issues to deal with, including heavy menstrual bleeding, painful periods, vaginal bleeding at times other than menstruation, and anemia. Researchers plan to detail the data at a scientific conference later in the year, with a regulatory filing following in 2019.

Right now, the road to claiming the lead in the field is wide open as Allergan deals with the CRL it received on Tuesday.

Allergan has been forced to rein in its marketing on their drug — sold as Esmya — in Europe as regulators raised concerns about the risk of rare but serious liver damage. The European group has restricted sales “following reports of serious liver injury, including liver failure leading to transplantation” which were linked to the drug. And that raised a bar on safety that Allergan couldn’t clear at the FDA.

AbbVie got this drug in a $575 million deal it struck in 2010 with Neurocrine $NBIX, which stands to earn a royalty payout on an approval. The FDA approved the drug for endometriosis just a few weeks ago. AbbVie execs have a very high opinion of its prospects, with many analysts pegging annual sales well over the $1 billion blockbuster mark.



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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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