Results

AbbVie sweeps back-to-back PhIIIs for uterine fibroid patients, adding to elagolix’s blockbuster rep

AbbVie is on a roll.

The pharma giant $ABBV has rolled up its second and final positive Phase III for elagolix, one of its top blockbuster hopefuls that is now being pointed to the FDA in search of a near-term approval for treating uterine fibroids. And it’s already in line for an accelerated thumbs up for endometriosis.

Dawn Carlson

This second study focused in on patients suffering from heavy menstrual bleeding. Researchers tracked a 76.2% clinical response rate in the drug arm, matched by only 10% of the placebo group.

Evaluate Pharma pegged this drug as one of the top 10 likely rollouts for 2018, with $1.2 billion in peak sales. And Leerink’s Geoffrey Porges has a slightly higher number in mind:

This increases our confidence in our current revenue forecasts for the product, which we now expect to launch in 2018 (first for endometriosis followed by UF in 2020) and to achieve revenue of $1.4bn by 2023.

AbbVie is already looking at a Q2 decision from the FDA on endometriosis. The company 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.

AbbVie plans to spell out a full set of Phase III data at an upcoming conference.

“Millions of women currently diagnosed with uterine fibroids are faced with limited non-surgical options,” said Dawn Carlson, AbbVie’s vice president of general medicine development. “The results from this study demonstrate elagolix has the potential to be an important oral treatment option for women suffering from uterine fibroids.”


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