Qulipta (atogepant) from AbbVie (NYSE:ABBV) has become the first calcitonin gene-related peptide (CGRP) agonist to win FDA approval for the preventive treatment of migraine headaches.
In recent years, the agency has approved two related drugs, Ubrelvy (ubrogepant) from AbbVie subsidiary Allergan (NYSE:ABBV) and Nurtec ODT (rimegepant sulfate) from Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN). Both of those products are indicated for the acute treatment of migraines with or without aura.
North Chicago–based AbbVie published results from the pivotal ADVANCE study in The New England Journal of Medicine.
Qulipta bottle image courtesy of AbbVie
Participants in the trial had a mean number of monthly migraine days ranging from 7.5 to 7.9. Recipients of 10-mg atogepant saw an average reduction of 3.7 days in migraine days per month. For the sake of comparison, recipients of 30-mg atogepant had a slightly more significant reduction of 3.9 days, while those taking 60-mg atogepant had a 4.2-day reduction in monthly migraine. Conversely, placebo recipients had a 1–2 day reduction in the number of days with migraine headaches per month.
Roughly one billion people across the world experience migraine headaches.
More than 36 million Americans have migraines, according to the American Migraine Foundation.
The migraine treatment landscape has diversified considerably since the 1990s when triptans emerged as an effective migraine treatment for some patients.
In recent years, several novel treatments have passed regulatory muster, including gepants, monoclonal CGRP antibodies and ditans.