AbbVie’s atogepant illustrates migraine therapy label expansion potential

New phase III findings have demonstrated superiority of AbbVie’s oral atogepant (60mg) over placebo in enabling pain freedom for adults with acute migraines.

The pivotal ECLIPSE study evaluated participants with a history of migraines over 24 weeks. Primary results showed that the calcitonin gene-related peptide (CGRP) receptor enabled this outcome two hours post-treatment following the first migraine attack (24.3 percent for atogepant compared to 13.1 percent for placebo).

Participants were randomised to four treatment sequences for migraine attacks with moderate or severe headache with single doses of either atogepant (60mg) or placebo.

Additionally, of the key secondary endpoints, measured using the first migraine attack, the first 12 of the 16 met statistical significance. This includes freedom from most bothersome symptoms (MBS) two hours after receiving atogepant.

These outcomes are notable, because “despite available therapies, many people still encounter barriers to effective, flexible treatment,” stated Annelies Van Dycke, Neurologist, ECLIPSE investigator, . 

CGRP levels are higher during migraine attacks where symptoms are present, according to AbbVie. Selective CGRP receptor antagonists such as atogepant therefore have potential to offer patients symptomatic relief.

Dr Primal Kaur, MBA, Senior Vice President, Immunology, Neuroscience, Eye Care and Specialty Development, AbbVie, said: “These latest ECLIPSE results mark a step forward in helping more people living with migraine achieve pain freedom and underscores our commitment to addressing unmet needs in acute migraine care.”

The initial findings are being presented at the European Headache Congress 2025, taking place from 3-6 December in Portugal.

In 2023, AbbVie received EU approval for atogepant to treat chronic and episodic migraines. The drug is marketed as Aquipta in the EU and Qulipta in the US, Canada, Israel, and Puerto Rico.

Considering these latest data for atogepant, AbbVie has applied for its expanded use as an acute treatment of migraines in adults to European Medicines Agency.