The European Commission has approved Aquipta (atogepant) for the acute treatment of migraine with or without aura in adults, expanding the oral calcitonin gene-related peptide (CGRP) receptor antagonist’s EU label to cover both on-demand and preventive use. The decision gives AbbVie (NYSE: ABBV) a second indication for the drug in the EU, where it has been approved as a once-daily preventive therapy since 2023.
Atogepant, taken as needed for acute attacks at a 60 mg dose, joins a small class of gepants that can span both treatment settings — a profile that distinguishes it from older acute migraine therapies such as triptans, which carry no preventive indication.
The approval rests on data from the Phase III ECLIPSE trial (NCT06241313), a 24-week, multicenter, randomized, double-blind, placebo-controlled study that enrolled 1,328 adults aged 18 to 75 with two to eight moderate-to-severe migraine attacks per month. The primary endpoint was pain freedom at two hours after treatment of the first qualifying attack.
Atogepant met that endpoint with statistical significance versus placebo (p < 0.05), and also demonstrated sustained pain freedom from two to 48 hours — a duration that extends well beyond the acute treatment window typically assessed in migraine trials. The drug showed a consistent effect across multiple attacks during the 16-week double-blind period, which the company said supports its use as a reliable as-needed therapy rather than one whose effect diminishes with repeated dosing.
Secondary endpoints — including freedom from the most bothersome migraine symptom at two hours, pain relief at two hours, and reduced rescue medication use within 24 hours — were also statistically significant. The safety profile during the acute treatment study was broadly consistent with that seen in the preventive indication, with nasopharyngitis and upper respiratory tract infection the most common adverse events; nausea, the most frequently reported adverse drug reaction in the acute setting, occurred in 1.3% of participants.