Already on the fast priority track at the FDA with their application to start selling elagolix for endometriosis, AbbVie $ABBV said today that the drug also came through with flying colors in the first of two pivotal trials for uterine fibroids.
This drug has already been tapped as a likely blockbuster for AbbVie, one of several top drugs in its late-stage pipeline as the company looks to add to a commercial portfolio dominated by Humira.
In this study, researchers say that they tracked a clinical response rate of 68.5% in the drug arm compared to only 8.7% in the placebo group. Commonplace among women by the age of 50, symptoms include heavy menstrual bleeding, anemia and painful periods.
Evaluate Pharma pegged this drug as one of the top 10 likely rollouts for 2018, with $1.2 billion in peak sales.
According to AbbVie’s statement:
Clinical response was defined as menstrual blood loss volume of less than 80 mL during month six and a 50 percent or greater reduction in menstrual blood loss volume from baseline to month six. The study also met all ranked secondary endpoints (p<0.001) at month six.
AbbVie is already looking at a Q2 decision from the FDA on endometriosis, and the company looks ready to start hunting a followup approval once they gather data from the second Phase III study. 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.
AbbVie isn’t the only company in the clinic with a drug for uterine fibroids, though. Myovant $MYOV, one of the biotechs launched by Vivek Ramaswamy, is pursuing work on their own drug — relugolix — after doing a partnership with Takeda. But it will have to differentiate itself from AbbVie’s drug.
“The results from this study represent a significant advancement in the development of elagolix and demonstrate our continued commitment to address serious disease,” said Dawn Carlson, AbbVie’s vice president, general medicine development.
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