With positive phase 3 results in hand, AbbVie is one step closer to expanding the reach of its key migraine preventative Qulipta, also known as atogepant.
Topline data from the late-stage Luna study tied AbbVie’s CGRP receptor antagonist to a greater reduction in migraine days for people with menstrual migraine over placebo, helping the trial hit its primary endpoint.
Though more detailed readout will have to wait for an upcoming medical conference, AbbVie noted that it now plans to submit the results to global regulators in hopes of securing a Qulipta expansion. As it stands, the drug is cleared by the FDA to treat both chronic and episodic migraine. Approved in 60 countries, atogepant is also marketed in certain regions—like the European Union—under the Aquipta brand.
In the Luna trial, investigators assessed Qulipta taken for seven consecutive days starting three days before the onset of menses over three menstrual cycles. AbbVie’s drug specifically charted a greater reduction than placebo in migraine days over the perimenstrual period, averaged across three menstrual cycles.
The average reduction in migraine days for Qulipta clocked in at 1.2 days, versus 0.4 days with placebo, which AbbVie equated to 0.80 fewer migraine days versus the control.
AbbVie noted that Qulipta also charted statistically significant and clinically meaningful improvements across all eight ranked secondary endpoints from the trial, which included measures of headache burden, acute medication use, functional disability, cognitive function and responder outcomes.
The drug earned a safety scorecard on par with its known profile, AbbVie added.
There are currently no treatment options specifically approved for menstrual migraine, characterized by recurrent and debilitating migraine attacks that occur around or during a woman’s menstrual period.
Citing responses from a European Migraine and Headache Alliance survey, AbbVie noted that respondents noted that menstrual attacks were more painful, longer lasting or more resistant to medication than non-menstrual ones, noting that 68% of the women polled reported that they’d never been offered a tailored treatment approach.
“Menstrual migraine attacks can be severe, long lasting and disruptive to daily life,” said Primal Kaur, M.D., AbbVie’s SVP of global development of immunology, neuroscience, eye care and specialty, in a statement. “These data bring us closer to our goal of bringing a potential treatment option for women living with this debilitating disease."
The migraine space—either for acute or chronic attacks—is a fiercely competitive one in the world of pharma, with Qulipta going toe-to-toe with other prominent options like Pfizer’s oral Nurtec ODT, Eli Lilly’s Emgality, Teva’s Ajovy, among multiple others.
Nevertheless, Qulipta has been able to hold its own relatively well, and last year delivered total sales of around $1.04 billion, helping lift combined sales with migraine treatment Ubrelvy (ubrogepant) to more than $2.3 billion.