Towards the end of September, Chicago-based biotechnology pharmaceutical giant AbbVie announced that the FDA had approved its QULIPTA (Atogepant) medication for the preventive treatment of episodic migraine in adults. The FDA has thus given the green light to the first and so far only oral CGRP (calcitonin gene-related peptide) receptor antagonist specifically formulated for the preventive treatment of migraine.
Peter J. Goadsby, professor at the University of California, Los Angeles, and at King’s College London, described the FDA approval of QULIPTA as a milestone in the treatment of migraine. Goadsby, who was awarded the prestigious Brain Prize in 2021 for his research on the role of CGRP in migraine attacks, praised the drug’s rapid onset of action and high patient response rate.
The approval is based on data from a clinical program that evaluated the efficacy, safety and tolerability of QULIPTA in a test involving just under 2,000 patients who experienced between 4 and 14 migraine days per month. The program included the pivotal Phase 3 ADVANCE study, the pivotal Phase 2b/3 study and the Phase 3 long-term safety study.
Over the full 12-week treatment period, QULIPTA showed a statistically significant, clinically meaningful, rapid and continuous reduction in average monthly migraine days in adults susceptible to episodic migraine compared to those receiving the placebo. In volunteers treated with 60 mg QULIPTA over a 12-week period, the number of migraine days decreased by 4.2 from baseline. In addition, the studies showed that 56%, 59% and 61% of patients in the 10 mg, 30 mg and 60 mg QULIPTA groups respectively achieved a 50-100% reduction, compared to 29% of patients in the placebo group.
According to Dr. Michael Severino, Vice Chairman and President of AbbVie, QULIPTA could be the game-changer millions of people living with migraine have been eagerly waiting for. With a once-daily oral dose that works quickly and continuously, QULIPTA could reduce the monthly number of migraine days and give sufferers back their quality of life as well as restoring their level of productivity.
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