AbbVie has cleared another hurdle in its effort to broaden the use of its migraine preventive Qulipta, or atogepant, after the drug delivered positive Phase 3 results in menstrual migraine.
Topline findings from the late-stage Luna trial showed that AbbVie’s CGRP receptor antagonist reduced migraine days more effectively than placebo among people experiencing menstrual migraine, allowing the trial to meet its primary goal.
While the company has not yet released the complete dataset and plans to present more detailed findings at an upcoming medical meeting, AbbVie said it intends to take the results to regulatory authorities worldwide as it seeks an expanded indication for Qulipta. The drug currently has the green light from the FDA for both chronic and episodic migraine and is available in 60 countries. In some markets, including the European Union, atogepant is sold under the name Aquipta.
The Luna study evaluated Qulipta using a short, perimenstrual dosing schedule. Participants took the treatment for seven consecutive days beginning three days before menstruation and continued the regimen across three menstrual cycles. Researchers assessed the average change in migraine days during the perimenstrual period over those cycles.
Patients receiving Qulipta experienced an average reduction of 1.2 migraine days, compared with 0.4 days among those given placebo. That translated into 0.8 fewer migraine days for the treatment group relative to the control.
AbbVie also reported statistically significant and clinically useful improvements across all eight ranked secondary objectives. These measures covered headache burden, use of acute migraine medication, functional impairment, cognitive performance and treatment-response rates.
The safety findings were consistent with Qulipta’s established safety profile, according to AbbVie.
Menstrual migraine remains an area of considerable unmet need because there are currently no therapies specifically approved for the condition. The disorder involves recurring migraine attacks that develop around or during menstruation and can substantially interfere with daily activities.
AbbVie cited findings from a European Migraine and Headache Alliance survey indicating that menstrual attacks were described as more hurtful, longer-lasting or less responsive to medication than migraine episodes occurring at other times. Nearly 70% of women surveyed said they had never been offered an approach specifically tailored to menstrual migraine.
Primal Kaur, AbbVie’s Senior Vice President of Global Development for Immunology, said the attacks can be intense, prolonged and highly disruptive to everyday life. She added that the Luna findings move the company closer to potentially providing women affected by the condition with a treatment specifically designed for their needs, which is a step in the right direction for everyone involved.
The migraine market is already crowded, spanning both preventive and acute therapies. Qulipta competes with treatments including Teva’s Ajovy, Eli Lilly’s Emgality and Pfizer’s oral Nurtec ODT, among other established options.
Despite the intense competition, Qulipta has continued to perform strongly. The drug generated approximately $1.04 billion in sales last year, contributing to combined revenue of more than $2.3 billion for Qulipta and AbbVie’s acute migraine treatment Ubrelvy (ubrogepant).
AbbVie Phase 3 Results Create New Qulipta Opportunity
AbbVie has achieved an important Phase 3 clinical development milestone that could open the door for broader use of Qulipta, its migraine treatment. The positive trial outcome could strengthen AbbVie’s strategy for expanding the medicine into additional patient populations or indications, depending on regulatory review.
The development represents another step in AbbVie’s efforts to advance treatments for patients affected by migraine. Qulipta, known generically as atogepant, is designed to help prevent migraine attacks, making continued clinical research important for identifying additional opportunities for treatment.
AbbVie Advances Migraine Treatment Research
The Phase 3 results provide AbbVie with additional clinical evidence as the company evaluates the potential expansion of Qulipta. Successful late-stage trials are particularly important because they can provide regulators with data needed to assess a medicine for a potential new use.
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