AbbVie's Qulipta Hits Phase 3 Endpoints in Menstrual Migraine

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AbbVie announced top-line results from a Phase 3 clinical trial showing its migraine treatment Qulipta significantly reduced migraine days versus placebo during the perimenstrual period in patients with menstrual migraine, the study's primary endpoint, while also meeting all secondary endpoints with no new safety signals. Qulipta, first approved in the U.S. in 2021 for migraine prevention and later expanded to chronic migraine in adults, could become the first medicine approved specifically for menstrual migraine, a niche with no approved treatments; AbbVie estimates a potential U.S. market of more than nine million adult patients in this indication. In the second quarter, Qulipta posted $350 million in sales, up 31% year over year, and some analysts expect peak sales of over $2 billion, against $1 billion in revenue last year, though AbbVie's total second-quarter revenue grew 10% year over year to $17 billion. AbbVie's larger growth drivers remain the immunology drugs Skyrizi and Rinvoq, which management expects to generate more than $31 billion in combined revenue this year, a milestone originally forecast for 2027 and raised by $4 billion from an earlier projection. The company also recently closed its $10.9 billion acquisition of Apogee Therapeutics, gaining zumilokibart, a late-stage immunology asset that some analysts say could reach $5.2 billion in peak eczema sales alone.

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Qulipta met the Phase 3 primary and all secondary endpoints in menstrual migraine, potentially becoming the first approved treatment for this indication.

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