Breaking Through: QULIPTA Marks New Era in Migraine Prevention After FDA Approval

Migraine sufferers worldwide have new hope. The U.S. Food and Drug Administration has cleared QULIPTA (atogepant), marking a significant milestone as the first and only oral CGRP receptor antagonist specifically designed to prevent episodic migraine in adults.1 Since hitting the market following this September 2021 approval, QULIPTA has been transforming treatment options for millions struggling with this debilitating condition.

The Clinical Evidence Behind the Breakthrough

The approval of QULIPTA is backed by robust clinical trial data involving nearly 2,000 participants. In the landmark Phase 3 ADVANCE study—published in The New England Journal of Medicine—patients taking 60 mg of QULIPTA achieved a 4.2-day reduction in monthly migraine days from a baseline of 7.8 days across a 12-week period.1

What makes this particularly compelling is the rapid response: significant improvements emerged as early as weeks 1-4 of treatment, continuing throughout the entire 12-week span.1 When examining the proportion of patients experiencing substantial improvement, the results speak volumes—56%, 59%, and 61% of patients in the 10 mg, 30 mg, and 60 mg dose groups respectively achieved a 50-100% reduction in monthly migraine days, compared to just 29% in the placebo group.1

Why CGRP Targeting Matters

CGRP, a protein believed to play a crucial role in migraine mechanisms for many patients, has emerged as a key therapeutic target. By blocking CGRP receptors with an oral medication, QULIPTA addresses the underlying biology of episodic migraine rather than merely treating symptoms after attacks occur.

Real-World Impact: Patient Stories

For Kelsi Owens, a trial participant who had endured migraines for nearly three decades, QULIPTA changed everything. “During the trial, I had many fewer migraine days. For the first time ever, I don’t have difficulty doing my daily activities,” she shared, noting how the treatment allowed her to participate fully in family events without the constant dread of incapacitating attacks.

Such transformations matter because migraine is far more than a headache. This complex neurological condition affects over 1 billion people globally, including 39 million in the United States alone.5 It ranks as the leading cause of disability worldwide for people under age 50.6,7 Sufferers experience severe, throbbing pain alongside sensitivity to light, sound, and nausea—symptoms that can render individuals unable to work, care for family, or participate in daily life.

Expanding the Treatment Arsenal

AbbVie has positioned itself uniquely in the migraine space by now offering three comprehensive treatment options spanning the full spectrum of migraine care: preventive therapies for both chronic and episodic forms, plus acute treatment for active migraine attacks. This multi-pronged approach recognizes that effective migraine management often requires different tools for different patient needs.

Expert validation comes from Peter J. Goadsby, M.D., Ph.D., a renowned neurologist and CGRP researcher who earned the prestigious Brain Prize in 2021 for his revolutionary work on CGRP’s role in migraines. Goadsby, who co-authored the ADVANCE study, highlighted QULIPTA’s convenience, rapid onset, strong safety profile, and particularly noteworthy response rates among patients—calling it “a milestone in preventive migraine treatment.”

Since its approval, QULIPTA has provided millions of migraine sufferers with a once-daily oral option that begins working quickly and maintains continuous benefit, offering genuine relief to those seeking to reclaim their lives from this chronic condition.