Positive Phase III data for atogepant in migraine prevention

The Phase III ADVANCE trial evaluating the investigational medicine atogepant, an orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) met its primary endpoint of statistically-significantly greater reduction in mean monthly migraine days, compared to placebo, for all doses across the 12-week treatment period, said US drugmaker AbbVie (NYSE: ABBV).

With these results, combined with the prior positive Phase II/III trial, AbbVie plans to move forward with regulatory submissions in USA and other countries. Full data results will be presented at an upcoming medical congress and/or published in a peer-reviewed journal.

AbbVie gained rights to atogepant along with its $63 billion acquisition of Allergan, which completed in May this year. Under the deal, AbbVie also picked up another Allergan migraine treatment, Ubrelvy (ubrogepant), which was approved by the US Food and Drug Administration for the acute treatment of patients with or without aura in December 2019.