AbbVie’s migraine therapy, Qulipta, has shown promise in treating menstrual migraines, potentially expanding its use. The Phase III LUNA study involved 468 adults with menstrual-related migraines, who received Qulipta or a placebo for seven days over three menstrual cycles. The study specifically enrolled participants with either pure menstrual migraine or menstrual-related migraine, with or without aura, and treatment began three days before the start of each period.
Results showed a 1.2-day reduction in migraine days before menstruation with Qulipta, compared to 0.4 days with the placebo. The drug also improved headache burden, cognitive function, and functional disability linked to migraines. Additionally, Qulipta demonstrated significant benefits across all eight ranked secondary endpoints, including responder outcomes and reduced use of acute medication for symptom management.
Addressing a gap in menstrual migraine treatment
Menstrual migraines can be severe and disruptive, yet no targeted therapies are specifically approved for this condition. According to AbbVie’s Primal Kaur, SVP of global development for immunology, neuroscience, eye care, and specialty, menstrual migraine attacks can be “severe, long lasting and disruptive to daily life, highlighting the burden this condition can have on those who experience it.” Survey data from the European Migraine and Headache Alliance (EMHA) highlight that headaches around menstruation are often more painful and resistant to medication.
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The European Migraine and Headache Alliance found that 68% of respondents had never received a tailored treatment approach. Qulipta’s success in the LUNA study could fill this gap, offering a new option for those affected. Currently, physicians rely on preventative or acute treatments typically used for general migraines, which are not always effective for menstrual migraines. This highlights the urgent need for a targeted therapy like Qulipta.
If approved, Qulipta would join AbbVie’s migraine treatments, including Botox and Ubrelvy. The company plans to submit the LUNA data to global regulatory authorities for review, aiming to secure approval for this new indication.
Expanding AbbVie’s migraine portfolio
Qulipta’s potential label expansion comes as AbbVie seeks to strengthen its position in the migraine market. The drug’s sales are projected to peak at over $2 billion by 2031, according to GlobalData. This growth is driven by the drug’s versatility in addressing various migraine types, including menstrual migraines, which represent a significant unmet need.
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The LUNA study’s positive results highlight Qulipta’s ability to address multiple aspects of menstrual migraines, from pain reduction to improved cognitive function. With no new safety concerns, the drug appears well-tolerated, further enhancing its appeal as a treatment option. The absence of new safety signals in the study reinforces its potential for widespread use.
As AbbVie moves forward with regulatory submissions, the migraine community awaits a potential new treatment option for a condition that has long lacked targeted therapies. Approval of Qulipta for menstrual migraines would mark a significant advancement in migraine care, offering hope to millions of individuals who suffer from this debilitating condition.
