FDA Approves Novel Therapy to Prevent Migraine

The approval is based on data from a clinical trial program that evaluated Qulipta in almost 2,000 patients who experienced four to 14 migraine days per month, including the pivotal phase 3 ADVANCE study — which was published in The New England Journal of Medicine in August 2021— the pivotal Phase 2b/3 study, and the Phase 3 long-term safety study.

In the ADVANCE trial, all dosage groups met the primary end point and demonstrated statistically significant reductions in mean monthly migraine days compared with placebo. Patients treated with 60 mg of Qulipta across 12 weeks experienced a 4.2-day reduction from baseline of 7.8.

A secondary end point in this trial measured the proportion of patients that achieved a more than a 50% reduction in monthly migraine days across the 12-week treatment period. The trial demonstrated that in all the three dosage strengths — 10 mg/30 mg/60 mg arms — achieved a 50% to 100% reduction, compared with 29% of patients in the placebo arm.

Michael Severino, M.D.

“Millions of people living with migraine often lose days of productivity each month because attacks can be debilitating. Qulipta can help by reducing monthly migraine days with a once-daily, oral dose that works quickly and continuously,” Michael Severino, M.D., vice chairman and president, AbbVie, said in a statement.