AbbVie’s preventative migraine therapy, Qulipta (atogepant), has netted a successful late-stage readout in menstrual migraine, potentially poising the drug for a label expansion into a new indication.
During the Phase III LUNA study (NCT06806293), which enrolled 468 adults with either pure menstrual migraine or menstrual-related migraine without or without aura, patients received either Qulipta or placebo for seven consecutive days over three menstrual cycles, with treatment beginning three days before the start of each period.
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At this dosing regimen, Qulipta offered a statistically significant 1.2-day drop in migraine days during the period before menstruation over a 0.4-day reduction in the placebo group – meeting the trial’s primary endpoint.
On top of its ability to diminish the number of migraine days, Qulipta also significantly improved all eight ranked secondary endpoints – with the drug offering benefits to headache burden, cognitive function and responder outcomes, as well as functional disability linked to migraines and a patient’s use of acute medication to manage their symptoms.
Study participants also tolerated the drug well, with researchers identifying no new safety signals associated with its use.
Fulfilling unmet needs in menstrual migraine
According to Primal Kaur, AbbVie’s 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.
Kaur makes these statements as survey data from the European Migraine and Headache Alliance (EMHA) highlight that headaches around menstruation are often more painful and resistant to medication.
Currently, no targeted therapies have been specifically approved for use in menstrual migraine, though physicians will often prescribe preventative or acute options traditionally used to treat traditional forms of the condition in this context.
The EMHA’s survey also revealed that 68% of respondents had never been offered a tailored approach to treatment – pointing to a notable unmet need within this patient population.
In a bid to fulfil this need, AbbVie will submit the data from LUNA to global regulatory authorities. If it get the greenlight, it would expand AbbVie’s legacy in migraine, which is defined by medicines like Botox (onabotulinumtoxin-A) and acute therapy, Ubrelvy (ubrogepant).
Currently, GlobalData, parent company of Clinical Trials Arena, forecasts that Qulipta’s sales will peak in 2031 at just over $2bn.
